AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
FDA premarket approval P940040/S006 · decided 2005-12-14
Approval details
- PMA number
- P940040
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2005-11-17
- Decision date
- 2005-12-14
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MWA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- CHANGE TO THE PURIFICATION PROCESS.
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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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| cobas liat CT/NG/MG nucleic acid test (K253759) | Roche Molecular Systems, Inc. | 2026-05-15 |
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| cobas CMV (K252481) | Roche Molecular Systems, Inc. | 2025-11-03 |
| cobas HCV (K252484) | Roche Molecular Systems, Inc. | 2025-11-03 |
| cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455) | Roche Molecular Systems, Inc. | 2025-07-31 |