Atlas FDA

CIB

16 FDA 510(k) clearances · Product code

76 daysmedian time to decision
382 days90th percentile
16clearances measured

FDA profile

Official device name
Radioimmunoassay, Angiotensin I And Renin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1085
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS (K123763)Immunodiagnostic Systems , Ltd.2013-12-24
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT (K121944)DiaSorin, Inc.2013-01-01
CISBIO RENIN RIA TEST (K062120)Cis Bio International2007-03-30
ACTIVE RENIN IRMA (K061758)Diagnostic Systems Laboratories, Inc.2006-07-28
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) (K011128)Nichols Institute Diagnostics2001-09-06
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (K981607)Diagnostic Systems Laboratories, Inc.1998-05-27
BUHLMANN ANGIOSTENSIN II RIA (K954299)Buhlmann Laboratories AG1995-10-19
AI-PHOTODIAGNOSTIC (K940004)Pharmarceutical Discovery Corp.1995-08-04
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY (K925998)Nichols Institute Diagnostics1993-01-06
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI (K850054)E.I. Dupont DE Nemours & Co., Inc.1985-03-29
RENIN RADIOIMMUNOASSAY TEST KIT (K842966)Serono Diagnostics, Inc.1984-10-11
ANGIOTENSIN CONVERTING ENZYME (K833777)Immuno-Diagnostic Laboratories1984-01-30
RENAK (K831694)Hoffmann-La Roche, Inc.1983-07-19
ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY (K820616)E. R. Squibb & Sons, Inc.1982-03-26
RENCTK (K800774)Sorin Biomedica, Fiat, USA, Inc.1980-04-21
ANGIOTENSIN I IMMUTOPE KIT (K761267)Squibb & Sons, Inc.1976-12-30

Track CIB automatically

Every clearance here is in the API, with alerts when new ones post.