JHO · Electrophoretic Separation, Lipoproteins
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | JHO |
|---|---|
| Device Name | Electrophoretic Separation, Lipoproteins |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 | Helena Laboratories | Aug 15, 2002 | SESE |
| K022053 | HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 | Sebia | Jul 12, 2002 | SESE |
| K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Quantimetrix Corp. | Mar 8, 2002 | SESE |
| K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | Morax | Jan 17, 2002 | SESE |
| K013466 | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 | Helena Laboratories | Dec 21, 2001 | SESE |
| K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Quantimetrix Corp. | Jul 25, 2001 | SESE |
| K000603 | SPIFE CHOLESTEROL PROFILE KIT | Helena Laboratories | Apr 17, 2000 | SESE |
| K992971 | REP CHOLESTEROL PROFILE KIT | Helena Laboratories | Oct 18, 1999 | SESE |
| K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 | Morax | Oct 7, 1998 | SESE |
| K980650 | REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL | Helena Laboratories | May 1, 1998 | SESE |
| K971157 | MACRALP(A) ENZYME IMMUNOASSAY KIT | Strategic Diagnostics, Inc. | Apr 15, 1998 | SESE |
| K962914 | REP 3 QUTO-FLUR CHOLESTEROL-30 | Helena Laboratories | Jan 13, 1997 | SESE |
| K964471 | REP FLUR CHOLESTEROL-60 KIT | Helena Laboratories | Dec 23, 1996 | SESE |
| K960571 | RAPID ELECTROPHORESIS ANALYZER | Helena Laboratories | Oct 25, 1996 | SESE |
| K960785 | LFS LIPOGEL ASSAY KIT | Zaxis, Inc. | Sep 3, 1996 | SESE |
| K935162 | REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT | Helena Laboratories | Nov 10, 1994 | SESE |
| K940679 | REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 | Helena Laboratories | Sep 9, 1994 | SESE |
| K893223 | REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 | Helena Laboratories | Jun 9, 1989 | SESE |
| K881809 | REP LIPO KIT CAT. NO 3180 | Helena Laboratories | Jun 1, 1988 | SESE |
| K871319 | TITAN GEL MULTI-SLOT LIPO-17 SYSTEM | Helena Laboratories | Apr 22, 1987 | SESE |
Top Applicants
- Helena Laboratories — 15 clearances
- Beckman Instruments, Inc. — 2 clearances
- Morax — 2 clearances
- Quantimetrix Corp. — 2 clearances
- Corning Medical & Scientific — 1 clearance
