The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for C. Pth Radioimmunoassay Kit-cpthk.
| Device ID | K833768 |
| 510k Number | K833768 |
| Device Name: | C. PTH RADIOIMMUNOASSAY KIT-CPTHK |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | SORIN BIOMEDICA, FIAT, USA, INC. 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 | 1983-10-27 |
| Decision Date | 1983-12-29 |