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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry, micro, for clinical use
510(k) Number K964506
Device Name ROCHE COBAS AMPLICOR ANALYZER
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
SOMERVILLE,  NJ  08876 -3711
Applicant Contact ALEX WESOLOWSKI
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
SOMERVILLE,  NJ  08876 -3711
Correspondent Contact ALEX WESOLOWSKI
Regulation Number862.2170
Classification Product Code
JJF  
Date Received11/08/1996
Decision Date 05/21/1997
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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