The following data is part of a premarket notification filed by Alfa Biotech (uk) Ltd. with the FDA for Auraflex Tsh-3 200 Test Pack Model Number 80600, Auraflex Tsh-3 Calibrator Pack Model Number Number 80601 Auraflex Dil0.
| Device ID | K980574 |
| 510k Number | K980574 |
| Device Name: | AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | ALFA BIOTECH (UK) LTD. 4 SPRING LAKES ESTATE, DEADBROOK LANE Aldershot, GB Gu12 4uh |
| Contact | M J Taylor |
| Correspondent | M J Taylor ALFA BIOTECH (UK) LTD. 4 SPRING LAKES ESTATE, DEADBROOK LANE Aldershot, GB Gu12 4uh |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-03-24 |