The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Active Renin Immunoradiometric Assay.
| Device ID | K925998 |
| 510k Number | K925998 |
| Device Name: | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-27 |
| Decision Date | 1993-01-06 |