PartoSure Test
FDA premarket approval P160052/S001 · decided 2019-10-11
Approval details
- PMA number
- P160052
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- PartoSure Test
- Generic name
- Placental alpha microglobulin-1 immunoassay
- Applicant
- Qiagen, Inc.
- Date received
- 2018-05-11
- Decision date
- 2019-10-11
- Days to decision
- 518 days
- Decision code
- APPR
- Product code
- QBB
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ipsogen JAK2 RGQ PCR Kit (K172287) | Qiagen, Inc. | 2018-01-12 |
| ipsogen JAK2 RGQ PCR Kit (DEN160028) | Qiagen, Inc. | 2017-03-27 |