LPS — Urinary Homocystine (Nonquantitative) Test System Class II
FDA product code LPS covers "Urinary Homocystine (Nonquantitative) Test System", a Class II medical device regulated under 21 CFR 862.1377. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LPS
- Device Class
- Class II
- Regulation Number
- 862.1377
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K123930 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VE | May 15, 2013 |
| K121053 | diazyme laboratories | DIAZYME HOMOCYSTEINE POC TEST KIT | July 31, 2012 |
| K121533 | tosoh bioscience | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMO | June 15, 2012 |
| K113793 | roche | HOMOCYSTEINE TEST | June 5, 2012 |
| K112790 | axis-shield diagnostics | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | May 7, 2012 |
| K083222 | axis-shield diagnostics | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | July 31, 2009 |
| K080851 | anticancer | A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY | October 10, 2008 |
| K073640 | axis-shield diagnostics | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | April 24, 2008 |
| K071971 | diazyme laboratories | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZ | September 17, 2007 |
| K063701 | teco diagnostics | TECO HOMOCYSTEINE ENZYMATIC ASSAY | April 11, 2007 |
| K063206 | dade behring | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CON | December 28, 2006 |
| K062808 | catch incorporated | LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT | October 13, 2006 |
| K061598 | instrumentation laboratory | HEMOSIL HOMOCYSTEINE AND CONTROLS | September 22, 2006 |
| K061588 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT | July 21, 2006 |
| K061296 | diazyme laboratories | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALI | June 13, 2006 |
| K052788 | dade behring | N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H | March 29, 2006 |
| K033706 | polymedco | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS | February 4, 2004 |
| K032012 | diazyme laboratories | HOMOCYSTEINE MICROTITER PLATE ASSAY | September 3, 2003 |
| K030754 | anticancer | A/C ENZYMATIC HOMOCYSTEINE ASSAY | July 11, 2003 |
| K013606 | bayer diagnostics | ACS 180 HOMOCYSTEINE ASSAY | December 21, 2001 |