The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Beta-tsh-irma.
| Device ID | K853977 |
| 510k Number | K853977 |
| Device Name: | BETA-TSH-IRMA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Contact | James P Lee |
| Correspondent | James P Lee LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-26 |
| Decision Date | 1985-10-22 |