The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Gastrin Radioimmunoassay Test Kit.
| Device ID | K842965 |
| 510k Number | K842965 |
| Device Name: | GASTRIN RADIOIMMUNOASSAY TEST KIT |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| Applicant | SERONO DIAGNOSTICS, INC. 11 BROOKS DR. Braintree, MA 02184 |
| Contact | Miriam Stell |
| Correspondent | Miriam Stell SERONO DIAGNOSTICS, INC. 11 BROOKS DR. Braintree, MA 02184 |
| Product Code | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-27 |
| Decision Date | 1984-10-11 |