The following data is part of a premarket notification filed by Immuno Nuclear Corp. with the FDA for Gastrin 1-17 By Radioimmunoassay Kit.
| Device ID | K812727 |
| 510k Number | K812727 |
| Device Name: | GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Gastrin |
| Applicant | IMMUNO NUCLEAR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGC |
| CFR Regulation Number | 862.1325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-28 |
| Decision Date | 1981-11-05 |