FDA Product Code
FDA Product Code CIB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1085
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS | Immunodiagnostic Systems , Ltd. | 2013-12-24 | Traditional | PDF ↗ |
| K121944 | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT | DiaSorin, Inc. | 2013-01-01 | Traditional | PDF ↗ |
| K062120 | CISBIO RENIN RIA TEST | Cis Bio International | 2007-03-30 | Traditional | PDF ↗ |
| K061758 | ACTIVE RENIN IRMA | Diagnostic Systems Laboratories, Inc. | 2006-07-28 | Special | PDF ↗ |
| K011128 | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) | Nichols Institute Diagnostics | 2001-09-06 | Traditional | PDF ↗ |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | Diagnostic Systems Laboratories, Inc. | 1998-05-27 | Traditional | PDF ↗ |
| K954299 | BUHLMANN ANGIOSTENSIN II RIA | Buhlmann Laboratories AG | 1995-10-19 | Traditional | PDF ↗ |
| K940004 | AI-PHOTODIAGNOSTIC | Pharmarceutical Discovery Corp. | 1995-08-04 | Traditional | PDF ↗ |
| K925998 | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY | Nichols Institute Diagnostics | 1993-01-06 | Traditional | PDF ↗ |
| K850054 | RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI | E.I. Dupont DE Nemours & Co., Inc. | 1985-03-29 | Traditional | PDF ↗ |
| K842966 | RENIN RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | 1984-10-11 | Traditional | PDF ↗ |
| K833777 | ANGIOTENSIN CONVERTING ENZYME | Immuno-Diagnostic Laboratories | 1984-01-30 | Traditional | PDF ↗ |
| K831694 | RENAK | Hoffmann-La Roche, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K820616 | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | E. R. Squibb & Sons, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K800774 | RENCTK | Sorin Biomedica, Fiat, USA, Inc. | 1980-04-21 | Traditional | PDF ↗ |
| K761267 | ANGIOTENSIN I IMMUTOPE KIT | Squibb & Sons, Inc. | 1976-12-30 | Traditional | PDF ↗ |
Product code CIB · Class II · Clinical Chemistry. Data: openFDA.