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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, alt/sgpt
510(k) Number K941287
Device Name LIQUID ALT(SGPT) 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 Number862.1030
Classification Product Code
CKA  
Date Received03/17/1994
Decision Date 05/03/1994
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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