The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Gamma Dab[125i]pth Radioimmunoassay Kit.
| Device ID | K822944 |
| 510k Number | K822944 |
| Device Name: | GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-04 |
| Decision Date | 1982-12-30 |