The following data is part of a premarket notification filed by Biosyn Ltd. with the FDA for Gastrin Eia Model 06b-555017.
| Device ID | K961276 |
| 510k Number | K961276 |
| Device Name: | GASTRIN EIA MODEL 06B-555017 |
| Classification | Radioimmunoassay, Gastrin |
| Applicant | BIOSYN LTD. 10, MALONE RD. Belfast, IE |
| Contact | Conor D Mcgurk |
| Correspondent | Conor D Mcgurk BIOSYN LTD. 10, MALONE RD. Belfast, IE |
| Product Code | CGC |
| CFR Regulation Number | 862.1325 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-03 |
| Decision Date | 1996-05-30 |
| Summary: | summary |