The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tamdem-r Thyroid Stimulating Hormone Kit.
| Device ID | K822705 |
| 510k Number | K822705 |
| Device Name: | TAMDEM-R THYROID STIMULATING HORMONE KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | HYBRITECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-07 |
| Decision Date | 1982-10-13 |