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JHO — Electrophoretic Separation, Lipoproteins Class I

FDA Device Classification

Classification Details

Product Code
JHO
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
K022333helena laboratoriesSPIFE LIPPOROTEIN-12, MODEL 3344August 15, 2002
K022053sebiaHYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134July 12, 2002
K013662quantimetrixMODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSMarch 8, 2002
K012789moraxMODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123January 17, 2002
K013466helena laboratoriesSPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343December 21, 2001
K010337quantimetrixLIPOPRINT SYSTEM, LDL SUBFRACTIONSJuly 25, 2001
K000603helena laboratoriesSPIFE CHOLESTEROL PROFILE KITApril 17, 2000
K992971helena laboratoriesREP CHOLESTEROL PROFILE KITOctober 18, 1999
K974854moraxHYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIOctober 7, 1998
K980650helena laboratoriesREP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROLMay 1, 1998
K971157strategic diagnosticsMACRALP(A) ENZYME IMMUNOASSAY KITApril 15, 1998
K962914helena laboratoriesREP 3 QUTO-FLUR CHOLESTEROL-30January 13, 1997
K964471helena laboratoriesREP FLUR CHOLESTEROL-60 KITDecember 23, 1996
K960571helena laboratoriesRAPID ELECTROPHORESIS ANALYZEROctober 25, 1996
K960785zaxisLFS LIPOGEL ASSAY KITSeptember 3, 1996
K935162helena laboratoriesREP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KITNovember 10, 1994
K940679helena laboratoriesREP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222September 9, 1994
K893223helena laboratoriesREP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181June 9, 1989
K881809helena laboratoriesREP LIPO KIT CAT. NO 3180June 1, 1988
K871319helena laboratoriesTITAN GEL MULTI-SLOT LIPO-17 SYSTEMApril 22, 1987