Aptima HPV 16 18/45 Genotype Assay
FDA premarket approval P120007/S016 · decided 2018-09-13
Approval details
- PMA number
- P120007
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Aptima HPV 16 18/45 Genotype Assay
- Generic name
- Kit, rna detection, human papillomavirus
- Applicant
- Gen-Probe Incorporated
- Date received
- 2018-08-16
- Decision date
- 2018-09-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Change in release testing specifications of incoming raw materials.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |