The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Calcitonin Radioimmunoassay Kit.
| Device ID | K842907 |
| 510k Number | K842907 |
| Device Name: | CALCITONIN RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Calcitonin |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JKR |
| CFR Regulation Number | 862.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-24 |
| Decision Date | 1984-09-05 |