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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
510(k) Number K961431
Device Name LACTATE DEHYDROGENASE REAGENT SET
Applicant
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Applicant Contact WILLIAM F WALTERS
Correspondent
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Correspondent Contact WILLIAM F WALTERS
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received04/15/1996
Decision Date 06/03/1996
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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