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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name monitor,test,hiv-1
510(k) Number BK020018
Tradename Cobas Ampliscreen System
Device Name Monitor, Test, HIV-1
Original Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
p.o. box 9002
pleasanton,,  CA  94588 0900
Classification Product Code
MTL  
Date Received05/09/2002
Decision Date 11/26/2002
Decision substantially equivalent (SE)
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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