The following data is part of a premarket notification filed by Progenika Biopharma, S.a. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
| Device ID | BK170092 |
| 510k Number | BK170092 |
| Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| Classification | Quality Control For Molecular Immunohematology Tests |
| Applicant | Progenika Biopharma, S.A. ibaizabal Bidea, Edificio 504 parque Technologico De Bizkaia Derio, Bizkaia, Spain, 48160, |
| Product Code | PFK |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Abbrevia |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-09 |
| Decision Date | 2018-10-11 |