SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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) September 16, 1999
BIOCONTROL TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
Pennsylvania 0-10822 25-1229323
(State of other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
300 Indian Springs Road, Indiana, Pennsylvania 15701
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (412) 349-1811
_________________________________________________________________
(Former name or former address,
if changes since last report.)
Item 1. Change in Control of Registrant.
Not applicable.
Item 2. Acquisition or Disposition of Assets.
Not applicable.
Item 3. Bankruptcy or Receivership.
Not applicable.
Item 4. Changes in Registrant's Certifying Accountant
Not applicable.
Item 5. Other Events.
Biocontrol Technology, Inc. announced today that the
U.S. Food and Drug Administration has responded to the first module
in its Modular PMA submission for the Diasensor 2000 Noninvasive
Glucose Monitor. The module, which is centered on the manufacturing
process, was submitted to the FDA for review in May of this year.
Item 6. Resignation of Registrant's Directors.
Not Applicable
Item 7. Financial Statement, Pro Forma Financial Information
and Exhibits.
(a) Financial Statements and Businesses Acquired - Not Applicable.
(b) Pro Forma Financial Information - Not Applicable.
(c) Exhibits - Press Release.
SIGNATURES
Pursuant to the requirement of the Securities Exchange Act
of 1934, the Registrant has duly caused this Report to be signed
on its behalf by the undersigned hereunto duly authorized.
BIOCONTROL TECHNOLOGY, INC.
by /s/ Fred E. Cooper
Fred E. Cooper, CEO
DATED: September 16, 1999
BICO
BIOCONTROL TECHNOLOGY, INC
2275 Swallow Hill Road, Building 2500
Pittsburgh, PA 15220
Press Release
Investors Media
Diane McQuaide Susan Taylor
1.412.429.0673 phone 1.412.429.0673 phone
1.412.279.9690 fax 1.412.279.5041 fax
FDA RESPONDS TO BIOCONTROL'S DIASENSOR MODULAR SUBMISSION
Pittsburgh, PA - September 16, 1999 - Biocontrol Technology,
Inc. (OTCBB:BICO) announced today that the U.S. Food and Drug
Administration (FDA) has responded to the first module in its
Modular PMA submission for the Diasensor 2000 Noninvasive Glucose
Monitor. The module, which is centered on the manufacturing
process, was submitted to the FDA for review in May of this year.
The Company said that it has answered the FDA's requests in
its recent response and is working closely with the agency to
satisfy the FDA's requirements for approval of the module.
The FDA recently implemented the modular PMA submittal
process which allows medical device manufacturers to submit
application information for market approval one segment at a
time. Biocontrol will submit additional information in
subsequent modules to complete its PMA submission, which will
include clinical and nonclinical testing of its Diasensor
monitor.
The Company further announced that the FDA has scheduled a
meeting with Biocontrol in early October.
Biocontrol Technology has its corporate offices in
Pittsburgh, PA and is involved in the development and manufacture
of biomedical devices and environmental products. Subsidiary,
Diasensor.com, Inc., also located in Pittsburgh, PA owns the
patent, marketing and distribution rights to the sensor while
Biocontrol has the exclusive rights to the research and
development and manufacturing of the sensor.
WEBSITE: www.bico.com
INVESTOR RELATIONS NEWSLINE NUMBER: 1.800.357.6204
