LPS · Class II · 21 CFR 862.1377

FDA Product Code LPS: Urinary Homocystine (nonquantitative) Test System

Leading manufacturers include Diazyme Laboratories, Axis-Shield Diagnostics, Ltd. and Dade Behring, Inc..

29
Total
29
Cleared
109d
Avg days
1998
Since

FDA 510(k) Cleared Urinary Homocystine (nonquantitative) Test System Devices (Product Code LPS)

29 devices
1–24 of 29
Cleared May 15, 2013
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
K123930
Ortho-Clinical Diagnostics, Inc.
Chemistry · 146d
Cleared Jul 31, 2012
DIAZYME HOMOCYSTEINE POC TEST KIT
K121053
Diazyme Laboratories
Chemistry · 116d
Cleared Jun 15, 2012
ST AIA-PACK HOMOCYSTEINE
K121533
Tosoh Bioscience, Inc.
Chemistry · 22d
Cleared Jun 05, 2012
HOMOCYSTEINE TEST
K113793
Roche
Chemistry · 165d
Cleared May 07, 2012
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
K112790
Axis-Shield Diagnostics, Ltd.
Chemistry · 224d
Cleared Jul 31, 2009
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
K083222
Axis-Shield Diagnostics, Ltd.
Chemistry · 270d
Cleared Oct 10, 2008
A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
K080851
Anticancer, Inc.
Chemistry · 198d
Cleared Apr 24, 2008
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
K073640
Axis-Shield Diagnostics, Ltd.
Chemistry · 120d
Cleared Sep 17, 2007
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
K071971
Diazyme Laboratories
Chemistry · 62d
Cleared Apr 11, 2007
TECO HOMOCYSTEINE ENZYMATIC ASSAY
K063701
Teco Diagnostics
Chemistry · 119d
Cleared Dec 28, 2006
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206
Dade Behring, Inc.
Chemistry · 66d
Cleared Oct 13, 2006
LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
K062808
Catch Incorporated
Chemistry · 24d
Cleared Sep 22, 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598
Instrumentation Laboratory CO
Chemistry · 106d
Cleared Jul 21, 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
K061588
Ortho-Clinical Diagnostics, Inc.
Chemistry · 43d
Cleared Jun 13, 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
K061296
Diazyme Laboratories
Chemistry · 35d
Cleared Mar 29, 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788
Dade Behring, Inc.
Chemistry · 177d
Cleared Feb 04, 2004
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
K033706
Polymedco, Inc.
Chemistry · 70d
Cleared Sep 03, 2003
HOMOCYSTEINE MICROTITER PLATE ASSAY
K032012
Diazyme Laboratories
Chemistry · 65d
Cleared Jul 11, 2003
A/C ENZYMATIC HOMOCYSTEINE ASSAY
K030754
Anticancer, Inc.
Toxicology · 123d
Cleared Dec 21, 2001
ACS 180 HOMOCYSTEINE ASSAY
K013606
Bayer Diagnostics Corp.
Chemistry · 51d
Cleared Dec 18, 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
K013406
Bayer Diagnostics Corp.
Chemistry · 64d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011689
Catch, Inc.
Chemistry · 55d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011692
Intersect Systems, Inc.
Chemistry · 55d
Cleared Feb 05, 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597
Diagnostic Products Corp.
Toxicology · 76d

About Product Code LPS - Regulatory Context