ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
FDA premarket approval P940040/S001 · decided 2000-09-12
Approval details
- PMA number
- P940040
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Trade name
- ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2000-07-26
- Decision date
- 2000-09-12
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MWA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR CURRENT FACILITY PLANS, REVISED BATCH RECORDS, REVISED QC SPECIFICATIONS, REVISED PACKAGING ORDERS AND REVISED LABELS.
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510(k) clearances by this applicant
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