CIB — Radioimmunoassay, Angiotensin I And Renin Class II
FDA product code CIB covers "Radioimmunoassay, Angiotensin I And Renin", a Class II medical device regulated under 21 CFR 862.1085. Submissions are reviewed by the Clinical Chemistry panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CIB
- Device Class
- Class II
- Regulation Number
- 862.1085
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K123763 | immunodiagnostic systems | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIR | December 24, 2013 |
| K121944 | diasorin | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT | January 1, 2013 |
| K062120 | cis bio international | CISBIO RENIN RIA TEST | March 30, 2007 |
| K061758 | diagnostic systems laboratories | ACTIVE RENIN IRMA | July 28, 2006 |
| K011128 | nichols institute diagnostics | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AN | September 6, 2001 |
| K981607 | diagnostic systems laboratories | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | May 27, 1998 |
| K954299 | buhlmann laboratories | BUHLMANN ANGIOSTENSIN II RIA | October 19, 1995 |
| K940004 | pharmarceutical discovery | AI-PHOTODIAGNOSTIC | August 4, 1995 |
| K925998 | nichols institute diagnostics | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY | January 6, 1993 |
| K850054 | e.i. dupont de nemours and co | RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI | March 29, 1985 |
| K842966 | serono diagnostics | RENIN RADIOIMMUNOASSAY TEST KIT | October 11, 1984 |
| K833777 | immuno-diagnostic laboratories | ANGIOTENSIN CONVERTING ENZYME | January 30, 1984 |
| K831694 | hoffmann-la roche | RENAK | July 19, 1983 |
| K820616 | e. r. squibb and sons | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | March 26, 1982 |
| K800774 | sorin biomedica, fiat, usa | RENCTK | April 21, 1980 |
| K761267 | squibb and sons | ANGIOTENSIN I IMMUTOPE KIT | December 30, 1976 |