The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax L.s. Tsh Irma Test Kit.
| Device ID | K873303 |
| 510k Number | K873303 |
| Device Name: | BINAX L.S. TSH IRMA TEST KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Contact | Watkins, Phd |
| Correspondent | Watkins, Phd BINAX, INC. 95 DARLING AVE. S. Portland, ME 04106 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-18 |
| Decision Date | 1987-10-02 |