The following data is part of a premarket notification filed by Progenika Biopharma S.a., A Grifols Company with the FDA for A1at Genotyping Test.
| Device ID | K211115 |
| 510k Number | K211115 |
| Device Name: | A1AT Genotyping Test |
| Classification | Serpina1 Variant Detection System |
| Applicant | Progenika Biopharma S.A., A Grifols Company Ibaizabal Bidea, Edificio 504, Parque Tecnológico De Bizkaia Derio, ES 48160 |
| Contact | Diego Tejedor |
| Correspondent | Diego Tejedor Progenika Biopharma S.A., A Grifols Company Ibaizabal Bidea, Edificio 504, Parque Tecnológico De Bizkaia Derio, ES 48160 |
| Product Code | PZH |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-14 |
| Decision Date | 2021-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437013457101 | K211115 | 000 |
| 08437013457095 | K211115 | 000 |