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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K812837
Device Name ALKALINE PHOSPHATASE REAGENT SET
Applicant
Anco Medical Reagents & Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Anco Medical Reagents & Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1050
Classification Product Code
CJL  
Date Received10/09/1981
Decision Date 01/29/1982
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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