Product code CIB— Clinical Chemistry
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY
- Classification name
- Radioimmunoassay, Angiotensin I And Renin
- Device class
- Class 2
- Regulation
- 21 CFR 862.1085
- Advisory panel
- Clinical Chemistry
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code CIB
FDA has cleared devices under product code CIB between 1976 and 2013, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2013
- 2007
- 2006
- 2001
- 1998
- 1995
- 1993
- 1985
- 1984
- 1983
- 1982
- 1980
- 1976
Top applicants under product code CIB
Recent clearances under product code CIB
- K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
- K121944 — LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
- K062120 — CISBIO RENIN RIA TEST
- K061758 — ACTIVE RENIN IRMA
- K011128 — NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
- K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
- K954299 — BUHLMANN ANGIOSTENSIN II RIA
- K940004 — AI-PHOTODIAGNOSTIC
- K925998 — ACTIVE RENIN IMMUNORADIOMETRIC ASSAY
- K850054 — RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
- K842966 — RENIN RADIOIMMUNOASSAY TEST KIT
- K833777 — ANGIOTENSIN CONVERTING ENZYME
- K831694 — RENAK
- K820616 — ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY
- K800774 — RENCTK
- K761267 — ANGIOTENSIN I IMMUTOPE KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.