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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cresolphthalein complexone, calcium
510(k) Number K963292
Device Name COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE,  NJ  08876 -3771
Applicant Contact ANDREA CASPER
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE,  NJ  08876 -3771
Correspondent Contact ANDREA CASPER
Regulation Number862.1145
Classification Product Code
CIC  
Subsequent Product Codes
DBF   DDQ   DDR   DHR   JBQ  
JIT   JJX   JJY  
Date Received08/21/1996
Decision Date 10/31/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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