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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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