Product Code: JHO
FDA class 1
21 CFR 862.1475
Electrophoretic Separation, Lipoproteins
Clinical Chemistry
Electrophoretic Separation for Lipoproteins is a clinical chemistry test system that separates lipoprotein classes in serum by electrophoresis, allowing quantification of VLDL, LDL, and HDL fractions for lipid profiling and cardiovascular disease risk assessment. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JHO, regulated under 21 CFR 862.1475, within the Clinical Chemistry medical specialty. No special flags apply to this device.
510(k)s
26
FEI Numbers
4
Registration Numbers
4
Unique Applicants
9
Years Active
24
Basic Information
- Product Code
- JHO
- Device Class
- FDA class 1
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 26 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 | Aug 15, 2002 | Substantially Equivalent | Helena Laboratories |
| K022053 | HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 | Jul 12, 2002 | Substantially Equivalent | Sebia |
| K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Mar 08, 2002 | Substantially Equivalent | Quantimetrix Corp. |
| K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | Jan 17, 2002 | Substantially Equivalent | Morax |
| K013466 | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 | Dec 21, 2001 | Substantially Equivalent | Helena Laboratories |
| K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Jul 25, 2001 | Substantially Equivalent | Quantimetrix Corp. |
| K000603 | SPIFE CHOLESTEROL PROFILE KIT | Apr 17, 2000 | Substantially Equivalent | Helena Laboratories |
| K992971 | REP CHOLESTEROL PROFILE KIT | Oct 18, 1999 | Substantially Equivalent | Helena Laboratories |
| K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 | Oct 07, 1998 | Substantially Equivalent | Morax |
| K980650 | REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL | May 01, 1998 | Substantially Equivalent | Helena Laboratories |
| K971157 | MACRALP(A) ENZYME IMMUNOASSAY KIT | Apr 15, 1998 | Substantially Equivalent | Strategic Diagnostics, Inc. |
| K962914 | REP 3 QUTO-FLUR CHOLESTEROL-30 | Jan 13, 1997 | Substantially Equivalent | Helena Laboratories |
| K964471 | REP FLUR CHOLESTEROL-60 KIT | Dec 23, 1996 | Substantially Equivalent | Helena Laboratories |
| K960571 | RAPID ELECTROPHORESIS ANALYZER | Oct 25, 1996 | Substantially Equivalent | Helena Laboratories |
| K960785 | LFS LIPOGEL ASSAY KIT | Sep 03, 1996 | Substantially Equivalent | Zaxis, Inc. |
| K935162 | REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT | Nov 10, 1994 | Substantially Equivalent | Helena Laboratories |
| K940679 | REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 | Sep 09, 1994 | Substantially Equivalent | Helena Laboratories |
| K893223 | REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 | Jun 09, 1989 | Substantially Equivalent | Helena Laboratories |
| K881809 | REP LIPO KIT CAT. NO 3180 | Jun 01, 1988 | Substantially Equivalent | Helena Laboratories |
| K871319 | TITAN GEL MULTI-SLOT LIPO-17 SYSTEM | Apr 22, 1987 | Substantially Equivalent | Helena Laboratories |
| K854057 | PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE | Dec 05, 1985 | Substantially Equivalent | Beckman Instruments, Inc. |
| K833611 | TITAN GEL LIPOPROTEIN ELECTROPHORESIS | Mar 15, 1984 | Substantially Equivalent | Helena Laboratories |
| K802822 | PARAGON LIPOPROTEIN ELECTRO. REAG. KIT | Dec 11, 1980 | Substantially Equivalent | Beckman Instruments, Inc. |
| K791606 | GELMAN LIPOPROTEIN FRS SET. P/N 51213 | Sep 17, 1979 | Substantially Equivalent | Gelman Sciences, Inc. |
| K781970 | CHOLESTEROL REAGENT SUBSTRATE SET | Jan 03, 1979 | Substantially Equivalent | Corning Medical & Scientific |
| K780256 | HDL CHOLESTEROL METHOD | Mar 28, 1978 | Substantially Equivalent | Helena Laboratories |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.