The following data is part of a premarket notification filed by Alfa Biotech (uk) Ltd. with the FDA for Auraflex Ft3 150 Test Pack, Auraflex Ft3 Calibrator Pack.
| Device ID | K974027 |
| 510k Number | K974027 |
| Device Name: | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | ALFA BIOTECH (UK) LTD. 4 SPRING LAKES ESTATE, DEADBROOK LANE Aldershot, GB Gu12 4uh |
| Contact | M. John Taylor |
| Correspondent | M. John Taylor ALFA BIOTECH (UK) LTD. 4 SPRING LAKES ESTATE, DEADBROOK LANE Aldershot, GB Gu12 4uh |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-23 |
| Decision Date | 1998-02-02 |
| Summary: | summary |