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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K861638
Device Name KINETIC ALKALINE PHOSPHATASE REAGENT KIT
Applicant
Bio-Analytics Laboratories, Inc.
Box 388
Palm City,  FL  34990
Applicant Contact WILLIAM J BARRY
Correspondent
Bio-Analytics Laboratories, Inc.
Box 388
Palm City,  FL  34990
Correspondent Contact WILLIAM J BARRY
Regulation Number862.1050
Classification Product Code
CJE  
Date Received04/30/1986
Decision Date 05/29/1986
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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