The following data is part of a premarket notification filed by Alfa Biotech (uk) Ltd. with the FDA for Auraflex Ferritin 200 Test Pack 80500, Auraflex Ferritin Calibrator Pack 80501.
| Device ID | K974505 |
| 510k Number | K974505 |
| Device Name: | AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | ALFA BIOTECH (UK) LTD. UNIT 4, SPRING LAKES ESTATE, DEADBROOK LANE Aldershot Hants, GB Gu12 4uh |
| Contact | M John Taylor |
| Correspondent | M John Taylor ALFA BIOTECH (UK) LTD. UNIT 4, SPRING LAKES ESTATE, DEADBROOK LANE Aldershot Hants, GB Gu12 4uh |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-01 |
| Decision Date | 1998-02-17 |
| Summary: | summary |