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LPS — Urinary Homocystine (Nonquantitative) Test System Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K123930ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VEMay 15, 2013
K121053diazyme laboratoriesDIAZYME HOMOCYSTEINE POC TEST KITJuly 31, 2012
K121533tosoh bioscienceST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOJune 15, 2012
K113793rocheHOMOCYSTEINE TESTJune 5, 2012
K112790axis-shield diagnosticsAXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONMay 7, 2012
K083222axis-shield diagnosticsAXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100July 31, 2009
K080851anticancerA/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAYOctober 10, 2008
K073640axis-shield diagnosticsARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLSApril 24, 2008
K071971diazyme laboratoriesDIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZSeptember 17, 2007
K063701teco diagnosticsTECO HOMOCYSTEINE ENZYMATIC ASSAYApril 11, 2007
K063206dade behringDIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONDecember 28, 2006
K062808catch incorporatedLIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENTOctober 13, 2006
K061598instrumentation laboratoryHEMOSIL HOMOCYSTEINE AND CONTROLSSeptember 22, 2006
K061588ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT July 21, 2006
K061296diazyme laboratoriesDIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIJune 13, 2006
K052788dade behringN LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/HMarch 29, 2006
K033706polymedcoPOLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMSFebruary 4, 2004
K032012diazyme laboratoriesHOMOCYSTEINE MICROTITER PLATE ASSAYSeptember 3, 2003
K030754anticancerA/C ENZYMATIC HOMOCYSTEINE ASSAYJuly 11, 2003
K013606bayer diagnosticsACS 180 HOMOCYSTEINE ASSAYDecember 21, 2001