Product code LPS— Clinical Chemistry
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
- Classification name
- Urinary Homocystine (Nonquantitative) Test System
- Device class
- Class 2
- Regulation
- 21 CFR 862.1377
- Advisory panel
- Clinical Chemistry
- Total cleared
- 29
- First cleared
- Most recent
Market context for product code LPS
FDA has cleared devices under product code LPS between 1998 and 2013, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2013
- 2012
- 2009
- 2008
- 2007
- 2006
- 2004
- 2003
- 2001
- 1999
- 1998
Top applicants under product code LPS
Recent clearances under product code LPS
- K123930 — VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
- K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT
- K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
- K113793 — HOMOCYSTEINE TEST
- K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
- K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
- K080851 — A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
- K073640 — ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
- K071971 — DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
- K063701 — TECO HOMOCYSTEINE ENZYMATIC ASSAY
- K063206 — DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH
- K062808 — LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
- K061598 — HEMOSIL HOMOCYSTEINE AND CONTROLS
- K061588 — VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
- K061296 — DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
- K052788 — N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
- K033706 — POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
- K032012 — HOMOCYSTEINE MICROTITER PLATE ASSAY
- K030754 — A/C ENZYMATIC HOMOCYSTEINE ASSAY
- K013606 — ACS 180 HOMOCYSTEINE ASSAY
- K013406 — ADVIA CENTAUR HOMOCYSTEINE ASSAY
- K011689 — HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
- K011692 — HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
- K003597 — IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
- K993107 — BIO-RAD HOMOCYSTEINE BY HPLC
- K992858 — ABBOTT AXSYM HOMOCYSTEINE
- K992274 — MODIFICATION TO IMX HOMOCYSTEINE
- K982003 — DS30 HCY HOMOCYSTEINE ASSAY KIT
- K980907 — AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.