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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K870500
Device Name MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
Applicant
American Diagnostic Corp.
P.O. Box 89
Wheaton,  IL  60189
Applicant Contact CRAIG BONDA
Correspondent
American Diagnostic Corp.
P.O. Box 89
Wheaton,  IL  60189
Correspondent Contact CRAIG BONDA
Regulation Number862.1340
Classification Product Code
JIL  
Date Received02/04/1987
Decision Date 03/06/1987
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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