JHO · Class I · 21 CFR 862.1475

FDA Product Code JHO: Electrophoretic Separation, Lipoproteins

Leading manufacturers include Helena Laboratories, Quantimetrix Corp. and Beckman Instruments, Inc..

Total

Cleared

119d

Avg days

1978

Since

FDA 510(k) Cleared Electrophoretic Separation, Lipoproteins Devices (Product Code JHO)

26 devices

1–24 of 26

Cleared Aug 15, 2002

SPIFE LIPPOROTEIN-12, MODEL 3344

HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134

MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

SPIFE 2000/3000 LIPOPROTEIN

LIPOPRINT SYSTEM, LDL SUBFRACTIONS

SPIFE CHOLESTEROL PROFILE KIT

REP CHOLESTEROL PROFILE KIT

REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8

REP 3 QUTO-FLUR CHOLESTEROL-30

REP FLUR CHOLESTEROL-60 KIT

RAPID ELECTROPHORESIS ANALYZER

REP DIRECT-SEP CHOLESTEROL-15 KIT

REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222

REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181

REP LIPO KIT CAT. NO 3180

TITAN GEL MULTI-SLOT LIPO-17 SYSTEM

PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE

K854057

Beckman Instruments, Inc.

Chemistry · 63d

Cleared Mar 15, 1984

TITAN GEL LIPOPROTEIN ELECTROPHORESIS

PARAGON LIPOPROTEIN ELECTRO. REAG. KIT

K802822

Beckman Instruments, Inc.

Immunology · 31d

Cleared Sep 17, 1979

GELMAN LIPOPROTEIN FRS SET. P/N 51213

K791606

Gelman Sciences, Inc.

Chemistry · 28d

Cleared Jan 03, 1979

CHOLESTEROL REAGENT SUBSTRATE SET

K781970

Corning Medical & Scientific

Chemistry · 40d

Cleared Mar 28, 1978

HDL CHOLESTEROL METHOD

K780256

Helena Laboratories

Chemistry · 43d

About Product Code JHO - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Aug 15, 2002

Product Code Info

Code	JHO
Device class	Class I
CFR	21 CFR 862.1475
Panel	Chemistry

Verify on FDA.gov

View JHO classification on FDA.gov →