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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 K873761
Device Name MULTICHEM ALKALINE PHOSPHATASE (S0903)
Applicant
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Applicant Contact QUINCY E CRIDER,PHD
Correspondent
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Correspondent Contact QUINCY E CRIDER,PHD
Regulation Number862.1050
Classification Product Code
CJE  
Date Received09/16/1987
Decision Date 10/07/1987
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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