FDA Product Code
FDA Product Code LPS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1377
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123930 | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | 2013-05-15 | Traditional | PDF ↗ |
| K121053 | DIAZYME HOMOCYSTEINE POC TEST KIT | Diazyme Laboratories | 2012-07-31 | Traditional | PDF ↗ |
| K121533 | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET | Tosoh Bioscience, Inc. | 2012-06-15 | Traditional | PDF ↗ |
| K113793 | HOMOCYSTEINE TEST | Roche | 2012-06-05 | Traditional | PDF ↗ |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | Axis-Shield Diagnostics, Ltd. | 2012-05-07 | Traditional | PDF ↗ |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | Axis-Shield Diagnostics, Ltd. | 2009-07-31 | Traditional | PDF ↗ |
| K080851 | A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY | Anticancer, Inc. | 2008-10-10 | Traditional | PDF ↗ |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | Axis-Shield Diagnostics, Ltd. | 2008-04-24 | Traditional | PDF ↗ |
| K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL | Diazyme Laboratories | 2007-09-17 | Special | PDF ↗ |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | Teco Diagnostics | 2007-04-11 | Traditional | PDF ↗ |
| K063206 | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH | Dade Behring, Inc. | 2006-12-28 | Traditional | PDF ↗ |
| K062808 | LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT | Catch Incorporated | 2006-10-13 | Special | PDF ↗ |
| K061598 | HEMOSIL HOMOCYSTEINE AND CONTROLS | Instrumentation Laboratory CO | 2006-09-22 | Traditional | PDF ↗ |
| K061588 | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2006-07-21 | Traditional | PDF ↗ |
| K061296 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR | Diazyme Laboratories | 2006-06-13 | Special | PDF ↗ |
| K052788 | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H | Dade Behring, Inc. | 2006-03-29 | Traditional | PDF ↗ |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS | Polymedco, Inc. | 2004-02-04 | Traditional | PDF ↗ |
| K032012 | HOMOCYSTEINE MICROTITER PLATE ASSAY | Diazyme Laboratories | 2003-09-03 | Traditional | PDF ↗ |
| K030754 | A/C ENZYMATIC HOMOCYSTEINE ASSAY | Anticancer, Inc. | 2003-07-11 | Traditional | PDF ↗ |
| K013606 | ACS 180 HOMOCYSTEINE ASSAY | Bayer Diagnostics Corp. | 2001-12-21 | Traditional | PDF ↗ |
| K013406 | ADVIA CENTAUR HOMOCYSTEINE ASSAY | Bayer Diagnostics Corp. | 2001-12-18 | Traditional | PDF ↗ |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Intersect Systems, Inc. | 2001-07-25 | Traditional | PDF ↗ |
| K011689 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | Catch, Inc. | 2001-07-25 | Traditional | PDF ↗ |
| K003597 | IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 | Diagnostic Products Corp. | 2001-02-05 | Traditional | PDF ↗ |
| K993107 | BIO-RAD HOMOCYSTEINE BY HPLC | Bio-Rad | 1999-12-21 | Traditional | PDF ↗ |
| K992858 | ABBOTT AXSYM HOMOCYSTEINE | Abbott Laboratories | 1999-10-25 | Traditional | PDF ↗ |
| K992274 | MODIFICATION TO IMX HOMOCYSTEINE | Axis Biochemicals, Asa | 1999-10-06 | Traditional | PDF ↗ |
| K982003 | DS30 HCY HOMOCYSTEINE ASSAY KIT | Drew Scientific , Ltd. | 1999-02-11 | Traditional | PDF ↗ |
| K980907 | AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY | Axis Biochemicals, Asa | 1998-10-16 | Traditional | PDF ↗ |
Product code LPS · Class II · Clinical Chemistry. Data: openFDA.