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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 K954992
Device Name ROCHE COBAS INTEGRA REAGENT CASSETTES
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Applicant Contact MARIA FEIJOO
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Correspondent Contact MARIA FEIJOO
Regulation Number862.1100
Classification Product Code
CIT  
Subsequent Product Codes
CFJ   CFR   CKA   DAD   DCF  
DEM   DIF   DKJ   DKZ   DLJ   GTQ  
JGJ   JHN   JIX   JIY   JJY   JXN  
KHS   KLP   KLR   KXS   LDP   LEG  
LEH   LKL   MOJ  
Date Received10/31/1995
Decision Date 01/25/1996
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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