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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) April 25, 1997
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CHROMATICS COLOR SCIENCES INTERNATIONAL, INC.
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(Exact Name of Registrant as Specified in Charter)
New York 0-21168 13-3253392
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(State or Other (Commission File (IRS Employer
Jurisdiction of Number) Identification No.)
Incorporation)
5 East 80th Street, New York, New York 10021
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code (212) 717-6544
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(Former Name or Former Address, if Changed Since Last Report)
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Page 1 of 5 pages
Exhibit Index located on page 4
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ITEM 5. OTHER EVENTS
On April 25, 1997, Chromatics Color Sciences International, Inc., a
New York corporation, (the "Company") received a request for supplementary
information and clarifications from the U.S. Food and Drug Administration
("FDA") on its premarket notification (510(k)) submission regarding the
Company's Colormate III device for the non-invasive monitoring of bilirubin
infant jaundice. The Company must respond to the FDA within the required
thirty-day period; however, failure to do so will require the Company to either
request an extension or resubmit the 510(k) application. The FDA may have
further comments or requests based on the Company's responses.
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
CHROMATICS COLOR SCIENCES
INTERNATIONAL, INC.
By /s/ Darby S. Macfarlane
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Name: Darby S. Macfarlane
Title: Chief Executive Officer
Date: April 30, 1997
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EXHIBIT INDEX
Exhibit Description Page
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99 Chromatics Color Sciences 5
International Inc. Press
Release, dated April 27, 1997
4
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CHROMATICS COLOR SCIENCES
INTERNATIONAL, INC.
CONTACT: Darby S. Macfarlane
5 East 80th Street
New York, New York 10021
Tel: (212) 717-6544
Fax: (212) 717-6675
FOR IMMEDIATE RELEASE
April 28, 1997
CHROMATICS REPORTS FDA UPDATE
CHROMATICS COLOR SCIENCES INTERNATIONAL, INC. (NASDAQ: CCSI) announced
on Friday April 25, 1997, that they received a response from the U.S. Food and
Drug Administration (FDA) requesting supplemental information and clarification
on its premarket notification (510(k)) submission regarding the Company's
Colormate III device for the non-invasive monitoring of bilirubin infant
jaundice. The Company believes it will be able to respond to the FDA within the
required 30-day period; however, if the Company is not able to do so, it will
be required to either request an extension or refile the 510(k) submission. The
FDA may have further comments or requests based on the Company's responses.
Except for the historical information contained herein, certain of the
matters discussed are forward-looking statements that involve material risks to
and uncertainties in the Company's business which may cause actual results to
differ materially from those anticipated by the statements made herein. Such
risks and uncertainties include, among other things, the availability of any
needed financing, the Company's ability to implement its long range business
plan for various applications for its technologies, the impact of competition,
the obtaining of and compliance with regulatory approvals applicable to
proposed application of the Company's technology, the management of growth, and
other risks and uncertainties that may be detailed from time to time in the
Company's reports filed with the Securities and Exchange Commission, including
those set forth in the Form 10-KSB.
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