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LBR — Ldl & Vldl Precipitation, Hdl Class I

FDA Device Classification

Classification Details

Product Code
LBR
Device Class
Class I
Regulation Number
862.1475
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K143691roche diagnostics operations (rdo)LDLC3 LDL-Cholesterol Gen.3January 28, 2015
K072523general atomicsDIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSJanuary 22, 2008
K050823teco diagnosticsDIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORJuly 26, 2005
K023784hemagen diagnosticsRAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA December 24, 2002
K012593ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PROAugust 30, 2001
K992029elan diagnosticsATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSAugust 12, 1999
K992002pointe scientific, incAUTOHDL CHOLESTEROL REAGENT SETAugust 5, 1999
K991789elan holdingsATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSJuly 9, 1999
K990247polymer technology systemsMTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470May 28, 1999
K984303ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENTJanuary 28, 1999
K980772diagnostic chemicalsHDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51April 27, 1998
K980770diagnostic chemicalsHDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51April 21, 1998
K974733boehringer mannheimBOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROLJanuary 26, 1998
K973369roche diagnostic systemsROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)November 21, 1997
K971573genzymeN-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYMEJune 18, 1997
K962723trace americaTRACE HDL CHOLESTEROL - AUTOMATED (HOMOGENMarch 13, 1997
K962186genzymeN-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATORAugust 19, 1996
K954179schiapparelli biosystemsHDL PRECIPITATING REAGENTDecember 11, 1995
K944975reference diagnosticsMAGNETIC HDL CHOLESTEROL TESTAugust 2, 1995
K941744merchant house scientificPBI PLUS HDL PRECIPITATING REAGENTSeptember 6, 1994