Urinary Homocystine (Nonquantitative) Test System

FDA product code LPS · 29 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1377
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1998-10-16 – 2013-05-15

LPS 2013-05-15

VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III

Applicant Ortho-Clinical Diagnostics, Inc.

K number K123930

View details →

LPS 2012-07-31

DIAZYME HOMOCYSTEINE POC TEST KIT

Applicant Diazyme Laboratories

K number K121053

View details →

LPS 2012-06-15

ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET

Applicant Tosoh Bioscience, Inc.

K number K121533

View details →

LPS 2012-06-05

HOMOCYSTEINE TEST

Applicant Roche

K number K113793

View details →

LPS 2012-05-07

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

Applicant Axis-Shield Diagnostics, Ltd.

K number K112790

View details →

LPS 2009-07-31

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

Applicant Axis-Shield Diagnostics, Ltd.

K number K083222

View details →

LPS 2008-10-10

A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY

Applicant Anticancer, Inc.

K number K080851

View details →

LPS 2008-04-24

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

Applicant Axis-Shield Diagnostics, Ltd.

K number K073640

View details →

LPS 2007-09-17

DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL

Applicant Diazyme Laboratories

K number K071971

View details →

LPS 2007-04-11

TECO HOMOCYSTEINE ENZYMATIC ASSAY

Applicant Teco Diagnostics

K number K063701

View details →

LPS 2006-12-28

DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH

Applicant Dade Behring, Inc.

K number K063206

View details →

LPS 2006-10-13

LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT

Applicant Catch Incorporated

K number K062808

View details →

LPS 2006-09-22

HEMOSIL HOMOCYSTEINE AND CONTROLS

Applicant Instrumentation Laboratory CO

K number K061598

View details →

LPS 2006-07-21

VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K061588

View details →

LPS 2006-06-13

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR

Applicant Diazyme Laboratories

K number K061296

View details →

LPS 2006-03-29

N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H

Applicant Dade Behring, Inc.

K number K052788

View details →

LPS 2004-02-04

POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS

Applicant Polymedco, Inc.

K number K033706

View details →

LPS 2003-09-03

HOMOCYSTEINE MICROTITER PLATE ASSAY

Applicant Diazyme Laboratories

K number K032012

View details →

LPS 2003-07-11

A/C ENZYMATIC HOMOCYSTEINE ASSAY

Applicant Anticancer, Inc.

K number K030754

View details →

LPS 2001-12-21

ACS 180 HOMOCYSTEINE ASSAY

Applicant Bayer Diagnostics Corp.

K number K013606

View details →

LPS 2001-12-18

ADVIA CENTAUR HOMOCYSTEINE ASSAY

Applicant Bayer Diagnostics Corp.

K number K013406

View details →

LPS 2001-07-25

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT

Applicant Intersect Systems, Inc.

K number K011692

View details →

LPS 2001-07-25

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT

Applicant Catch, Inc.

K number K011689

View details →

LPS 2001-02-05

IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2

Applicant Diagnostic Products Corp.

K number K003597

View details →

LPS 1999-12-21

BIO-RAD HOMOCYSTEINE BY HPLC

Applicant Bio-Rad

K number K993107

View details →

LPS 1999-10-25

ABBOTT AXSYM HOMOCYSTEINE

Applicant Abbott Laboratories

K number K992858

View details →

LPS 1999-10-06

MODIFICATION TO IMX HOMOCYSTEINE

Applicant Axis Biochemicals, Asa

K number K992274

View details →

LPS 1999-02-11

DS30 HCY HOMOCYSTEINE ASSAY KIT

Applicant Drew Scientific , Ltd.

K number K982003

View details →

LPS 1998-10-16

AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY

Applicant Axis Biochemicals, Asa

K number K980907

View details →