The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Renin Radioimmunoassay Test Kit.
| Device ID | K842966 |
| 510k Number | K842966 |
| Device Name: | RENIN RADIOIMMUNOASSAY TEST KIT |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | SERONO DIAGNOSTICS, INC. 11 BROOKS DR. Braintree, MA 02184 |
| Contact | Miriam Stella |
| Correspondent | Miriam Stella SERONO DIAGNOSTICS, INC. 11 BROOKS DR. Braintree, MA 02184 |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-27 |
| Decision Date | 1984-10-11 |