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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 K012966
Device Name ROCHE COBAS TAQMAN ANALYZER
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DR.
PLEASANTON,  CA  94588 -2722
Applicant Contact GARY S RIORDAN
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DR.
PLEASANTON,  CA  94588 -2722
Correspondent Contact GARY S RIORDAN
Regulation Number862.2170
Classification Product Code
JJF  
Date Received09/04/2001
Decision Date 02/01/2002
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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