Panels › Clinical Chemistry › Product code LPS · Class 2
Urinary Homocystine (Nonquantitative) Test System
Regulation 862.1377
0510(k)s in 12 months (29 all time)
0recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in LPS
| Company | 510(k)s | Recalls |
|---|---|---|
| Axis-Shield Diagnostics, Ltd. | 3 | 4 |
| Catch Incorporated | 2 | 2 |
| Diazyme Laboratories | 4 | 0 |
| Siemens Healthcare Diagnostics, Inc | 0 | 4 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 1 |
| Roche Diagnostics Operations, Inc. | 0 | 3 |
| Anticancer, Inc. | 2 | 0 |
| Axis Biochemicals, Asa | 2 | 0 |
| Bayer Diagnostics Corp. | 2 | 0 |
| Dade Behring, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2013 | K123930 | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc. | LPS |
| Jul 31, 2012 | K121053 | DIAZYME HOMOCYSTEINE POC TEST KIT Diazyme Laboratories | LPS |
| Jun 15, 2012 | K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET Tosoh Bioscience, Inc. | LPS |
| Jun 5, 2012 | K113793 | HOMOCYSTEINE TEST Roche | LPS |
| May 7, 2012 | K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON Axis-Shield Diagnostics, Ltd., GB | LPS |
| Jul 31, 2009 | K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 Axis-Shield Diagnostics, Ltd., GB | LPS |
| Oct 10, 2008 | K080851 | A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY Anticancer, Inc. | LPS |
| Apr 24, 2008 | K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS Axis-Shield Diagnostics, Ltd., GB | LPS |
| Sep 17, 2007 | K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL Diazyme Laboratories | LPS |
| Apr 11, 2007 | K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY Teco Diagnostics | LPS |
| Dec 28, 2006 | K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH Dade Behring, Inc. | LPS |
| Oct 13, 2006 | K062808 | LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT Catch Incorporated | LPS |
| Sep 22, 2006 | K061598 | HEMOSIL HOMOCYSTEINE AND CONTROLS Instrumentation Laboratory CO | LPS |
| Jul 21, 2006 | K061588 | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc. | LPS |
| Jun 13, 2006 | K061296 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR Diazyme Laboratories | LPS |
| Mar 29, 2006 | K052788 | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H Dade Behring, Inc. | LPS |
| Feb 4, 2004 | K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS Polymedco, Inc. | LPS |
| Sep 3, 2003 | K032012 | HOMOCYSTEINE MICROTITER PLATE ASSAY Diazyme Laboratories | LPS |
| Jul 11, 2003 | K030754 | A/C ENZYMATIC HOMOCYSTEINE ASSAY Anticancer, Inc. | LPS |
| Dec 21, 2001 | K013606 | ACS 180 HOMOCYSTEINE ASSAY Bayer Diagnostics Corp. | LPS |
| Dec 18, 2001 | K013406 | ADVIA CENTAUR HOMOCYSTEINE ASSAY Bayer Diagnostics Corp. | LPS |
| Jul 25, 2001 | K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT Intersect Systems, Inc. | LPS |
| Jul 25, 2001 | K011689 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT Catch, Inc. | LPS |
| Feb 5, 2001 | K003597 | IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 Diagnostic Products Corp. | LPS |
| Dec 21, 1999 | K993107 | BIO-RAD HOMOCYSTEINE BY HPLC Bio-Rad | LPS |
| Oct 25, 1999 | K992858 | ABBOTT AXSYM HOMOCYSTEINE Abbott Laboratories | LPS |
| Oct 6, 1999 | K992274 | MODIFICATION TO IMX HOMOCYSTEINE Axis Biochemicals, Asa | LPS |
| Feb 11, 1999 | K982003 | DS30 HCY HOMOCYSTEINE ASSAY KIT Drew Scientific , Ltd., GB | LPS |
| Oct 16, 1998 | K980907 | AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY Axis Biochemicals, Asa | LPS |
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