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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 K900121
Device Name ROCHE REAGENT FOR LDH
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
MONTCLAIR,  NJ  07042
Applicant Contact ALEX WESOLOWSKI
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
MONTCLAIR,  NJ  07042
Correspondent Contact ALEX WESOLOWSKI
Regulation Number862.1440
Classification Product Code
CFJ  
Date Received01/09/1990
Decision Date 03/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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