The following data is part of a premarket notification filed by Immuno Nuclear Corp. with the FDA for Min-molecule Pth By Radioimmunoassay.
| Device ID | K820228 |
| 510k Number | K820228 |
| Device Name: | MIN-MOLECULE PTH BY RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | IMMUNO NUCLEAR CORP. 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 | 1982-01-27 |
| Decision Date | 1982-03-11 |