Atlas FDA

LPS

29 FDA 510(k) clearances · Product code

92 daysmedian time to decision
224 days90th percentile
29clearances measured

FDA profile

Official device name
Urinary Homocystine (Nonquantitative) Test System
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1377
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III (K123930)Ortho-Clinical Diagnostics, Inc.2013-05-15
DIAZYME HOMOCYSTEINE POC TEST KIT (K121053)Diazyme Laboratories2012-07-31
ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET (K121533)Tosoh Bioscience, Inc.2012-06-15
HOMOCYSTEINE TEST (K113793)Roche2012-06-05
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (K112790)Axis-Shield Diagnostics, Ltd.2012-05-07
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (K083222)Axis-Shield Diagnostics, Ltd.2009-07-31
A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY (K080851)Anticancer, Inc.2008-10-10
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS (K073640)Axis-Shield Diagnostics, Ltd.2008-04-24
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL (K071971)Diazyme Laboratories2007-09-17
TECO HOMOCYSTEINE ENZYMATIC ASSAY (K063701)Teco Diagnostics2007-04-11
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH (K063206)Dade Behring, Inc.2006-12-28
LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT (K062808)Catch Incorporated2006-10-13
HEMOSIL HOMOCYSTEINE AND CONTROLS (K061598)Instrumentation Laboratory CO2006-09-22
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS (K061588)Ortho-Clinical Diagnostics, Inc.2006-07-21
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR (K061296)Diazyme Laboratories2006-06-13
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H (K052788)Dade Behring, Inc.2006-03-29
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS (K033706)Polymedco, Inc.2004-02-04
HOMOCYSTEINE MICROTITER PLATE ASSAY (K032012)Diazyme Laboratories2003-09-03
A/C ENZYMATIC HOMOCYSTEINE ASSAY (K030754)Anticancer, Inc.2003-07-11
ACS 180 HOMOCYSTEINE ASSAY (K013606)Bayer Diagnostics Corp.2001-12-21
ADVIA CENTAUR HOMOCYSTEINE ASSAY (K013406)Bayer Diagnostics Corp.2001-12-18
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (K011692)Intersect Systems, Inc.2001-07-25
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (K011689)Catch, Inc.2001-07-25
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 (K003597)Diagnostic Products Corp.2001-02-05
BIO-RAD HOMOCYSTEINE BY HPLC (K993107)Bio-Rad1999-12-21
ABBOTT AXSYM HOMOCYSTEINE (K992858)Abbott Laboratories1999-10-25
MODIFICATION TO IMX HOMOCYSTEINE (K992274)Axis Biochemicals, Asa1999-10-06
DS30 HCY HOMOCYSTEINE ASSAY KIT (K982003)Drew Scientific , Ltd.1999-02-11
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY (K980907)Axis Biochemicals, Asa1998-10-16

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