COBAS TAQMAN HBV TEST
FDA premarket approval P050028/S006 · decided 2010-04-08
Approval details
- PMA number
- P050028
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS TAQMAN HBV TEST
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2009-12-24
- Decision date
- 2010-04-08
- Days to decision
- 105 days
- Decision code
- OK30
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- ROOM CHANGES FOR THE MANUFACTURE OF QUANTITATION STANDARD AND INTERNAL CONTROL REAGENTS.
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510(k) clearances by this applicant
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|---|---|---|
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
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