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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K801536
Device Name BLOOD GLUCOSE TESTER
Applicant
BROOMER RESEARCH CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BROOMER RESEARCH CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received07/03/1980
Decision Date 09/16/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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