The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for Gastrin Radioimmunoassay Test.
| Device ID | K810722 |
| 510k Number | K810722 |
| Device Name: | GASTRIN RADIOIMMUNOASSAY TEST |
| Classification | Radioimmunoassay, Gastrin |
| Applicant | CLINICAL ASSAYS, INC. 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 | 1981-03-17 |
| Decision Date | 1981-05-27 |