Atlas FDA

NDY

22 FDA 510(k) clearances · Product code

95 daysmedian time to decision
265 days90th percentile
22clearances measured

FDA profile

Official device name
Test, Cystatin C
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1225
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
Cystatin C (K242585)SENTINEL CH. SpA2025-05-16
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) (K181082)Siemens Healthcare Diagnostics, Inc.2018-05-25
N Latex Cystatin C; N Protein Standard UY (K171072)Siemens Healthcare Diagnostics Products GmbH2017-05-12
Tina-quant Cystatin C Gen.2 (K161817)Roche Diagnostics Operations (Rdo)2016-07-27
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET (K141143)Roche Diagnostics2014-07-17
DIAZYME CYSTATIN C POC TEST KIT (K111664)Diazyme Laboratories2012-03-30
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL (K093137)Kamiya Biomedical Co.2010-09-28
ST AIA-PACK CYSTATIN C, MODEL 025217 (K093960)Tosoh Bioscience, Inc.2010-09-14
DIAZYME CYSTATIN C ASSAY (K093680)Diazyme Laboratories2010-04-08
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 (K083906)Siemens Healthcare Diagnostics2009-03-11
GENTIAN CYSTATIN C IMMUNOASSAY (K081875)Gentian AS2008-08-20
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET (K080811)Roche Diagnostics Corp.2008-06-20
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER (K080384)The Binding Site, Ltd.2008-06-06
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR (K080662)Genzyme Corporation2008-05-15
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) (K072270)Diazyme Laboratories2008-02-01
CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER (K072166)The Binding Site2008-01-24
GENTIAN CYSTATIN C IMMUNOASSAY (K071388)Gentian AS2007-11-06
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH (K063647)Thermo Electron OY2007-03-12
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH (K063351)Dade Behring, Inc.2007-01-22
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR (K041627)Dako A/S2004-09-03
N LATEX CYSTATIN (K041878)Dade Behring, Inc.2004-08-16
N LATEX CYSTATIN C (K003503)Dade Behring, Inc.2001-03-13

Track NDY automatically

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