Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | COBAS AMPLIPREP/COBAS TAQMAN HBV TEST |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P050028 |
Supplement Number | S008 |
Date Received | 08/05/2010 |
Decision Date | 08/30/2010 |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement SCALE-UP OF A MANUFACTURING PROCESS. |
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