APTIMA HPV ASSAY
FDA premarket approval P100042/S003 · decided 2014-07-07
Approval details
- PMA number
- P100042
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Trade name
- APTIMA HPV ASSAY
- Generic name
- Kit, rna detection, human papillomavirus
- Applicant
- Gen-Probe Incorporated
- Date received
- 2014-06-09
- Decision date
- 2014-07-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- CHANGE TO REVISE AN INTERNAL CONTROL QC RELEASE TEST SPECIFICATION FOR THE APTIMA® HPV ASSAY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |