A1AT Genotyping Test
FDA 510(k) clearance K192858 · decided 2019-11-05
Clearance details
- K-number
- K192858
- Device name
- A1AT Genotyping Test
- Applicant
- Progenika Biopharma S.A., A Grifols Company
- Decision
- Substantially Equivalent
- Date received
- 2019-10-04
- Decision date
- 2019-11-05
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- PZH
- Device class
- 2
- Regulation number
- 866.5130
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Derio, ES
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| A1AT Genotyping Test (K211115) | Progenika Biopharma S.A., A Grifols Company | 2021-05-13 |
| A1AT Genotyping Test (K171868) | Progenika Biopharma S.A., A Grifols Company | 2017-11-11 |
Recalls involving this device
No recalls on record reference this clearance.