COBAS HPV TEST
FDA premarket approval P100020/S002 · decided 2012-10-18
Approval details
- PMA number
- P100020
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS HPV TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-12-12
- Decision date
- 2012-10-18
- Days to decision
- 311 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A CHANGE IN THE DNA SYNTHESIZER INSTRUMENT PLATFORM.
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510(k) clearances by this applicant
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|---|---|---|
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