Panels › Clinical Chemistry › Product code CIB · Class 2
Radioimmunoassay, Angiotensin I And Renin
Regulation 862.1085
0510(k)s in 12 months (16 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in CIB
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 2 | 0 |
| DiaSorin, Inc. | 1 | 1 |
| Nichols Institute Diagnostics | 2 | 0 |
| Perkinelmer Life Sciences, Inc. | 0 | 2 |
| Beckman Coulter Inc. | 0 | 1 |
| Buhlmann Laboratories AG | 1 | 0 |
| Cis Bio International | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| E. R. Squibb & Sons, Inc. | 1 | 0 |
| Hoffmann-La Roche, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 24, 2013 | K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS Immunodiagnostic Systems , Ltd., GB | CIB |
| Jan 1, 2013 | K121944 | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT DiaSorin, Inc. | CIB |
| Mar 30, 2007 | K062120 | CISBIO RENIN RIA TEST Cis Bio International | CIB |
| Jul 28, 2006 | K061758 | ACTIVE RENIN IRMA Diagnostic Systems Laboratories, Inc. | CIB |
| Sep 6, 2001 | K011128 | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) Nichols Institute Diagnostics | CIB |
| May 27, 1998 | K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 Diagnostic Systems Laboratories, Inc. | CIB |
| Oct 19, 1995 | K954299 | BUHLMANN ANGIOSTENSIN II RIA Buhlmann Laboratories AG | CIB |
| Aug 4, 1995 | K940004 | AI-PHOTODIAGNOSTIC Pharmarceutical Discovery Corp. | CIB |
| Jan 6, 1993 | K925998 | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY Nichols Institute Diagnostics | CIB |
| Mar 29, 1985 | K850054 | RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI E.I. Dupont DE Nemours & Co., Inc. | CIB |
| Oct 11, 1984 | K842966 | RENIN RADIOIMMUNOASSAY TEST KIT Serono Diagnostics, Inc. | CIB |
| Jan 30, 1984 | K833777 | ANGIOTENSIN CONVERTING ENZYME Immuno-Diagnostic Laboratories | CIB |
| Jul 19, 1983 | K831694 | RENAK Hoffmann-La Roche, Inc. | CIB |
| Mar 26, 1982 | K820616 | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY E. R. Squibb & Sons, Inc. | CIB |
| Apr 21, 1980 | K800774 | RENCTK Sorin Biomedica, Fiat, USA, Inc. | CIB |
| Dec 30, 1976 | K761267 | ANGIOTENSIN I IMMUTOPE KIT Squibb & Sons, Inc. | CIB |
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