COBAS TAQMAN HBV TEST
FDA premarket approval P050028/S001 · decided 2008-11-12
Approval details
- PMA number
- P050028
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS TAQMAN HBV TEST
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2008-10-06
- Decision date
- 2008-11-12
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE SHELF LIFE EXTENSION OF THE TAQMAN HBV TEST COMPONENTS/KITS IN THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM.
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510(k) clearances by this applicant
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