FDA 510(k) Applications for Medical Device Product Code: JHO (Electrophoretic Separation, Lipoproteins)

FDA 510(k) Applications for Medical Device Product Code "JHO"
(Electrophoretic Separation, Lipoproteins)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K960571	HELENA LABORATORIES	RAPID ELECTROPHORESIS ANALYZER	10/25/1996
K962914	HELENA LABORATORIES	REP 3 QUTO-FLUR CHOLESTEROL-30	01/13/1997
K992971	HELENA LABORATORIES	REP CHOLESTEROL PROFILE KIT	10/18/1999
K980650	HELENA LABORATORIES	REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL	05/01/1998
K964471	HELENA LABORATORIES	REP FLUR CHOLESTEROL-60 KIT	12/23/1996
K013466	HELENA LABORATORIES	SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343	12/21/2001
K000603	HELENA LABORATORIES	SPIFE CHOLESTEROL PROFILE KIT	04/17/2000
K022333	HELENA LABORATORIES	SPIFE LIPPOROTEIN-12, MODEL 3344	08/15/2002
K974854	MORAX	HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207	10/07/1998
K012789	MORAX	MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123	01/17/2002
K010337	QUANTIMETRIX CORP.	LIPOPRINT SYSTEM, LDL SUBFRACTIONS	07/25/2001
K013662	QUANTIMETRIX CORP.	MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS	03/08/2002
K022053	SEBIA	HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134	07/12/2002
K971157	STRATEGIC DIAGNOSTICS, INC.	MACRALP(A) ENZYME IMMUNOASSAY KIT	04/15/1998
K960785	ZAXIS, INC.	LFS LIPOGEL ASSAY KIT	09/03/1996