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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Ast/Sgot
510(k) Number K941132
Device Name LIQUID AST (SGOT)REAGENT SET
Applicant
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Applicant Contact WILLIAM F WALTERS,JR
Correspondent
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Correspondent Contact WILLIAM F WALTERS,JR
Regulation Number862.1100
Classification Product Code
CIT  
Date Received03/09/1994
Decision Date 05/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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