The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Tsh-stat.
| Device ID | K844583 |
| 510k Number | K844583 |
| Device Name: | TSH-STAT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 1800 HURD DR. P.O. BOX 2860 Irving, TX 75061 |
| Contact | Robert D Wurzel |
| Correspondent | Robert D Wurzel NUCLEAR MEDICAL LABORATORIES, INC. 1800 HURD DR. P.O. BOX 2860 Irving, TX 75061 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-23 |
| Decision Date | 1985-03-05 |