Atlas FDA

JHO

26 FDA 510(k) clearances · Product code

64 daysmedian time to decision
282 days90th percentile
26clearances measured

FDA profile

Official device name
Electrophoretic Separation, Lipoproteins
Device class
Class I (low risk)
Regulation
21 CFR 862.1475
Medical specialty
Clinical Chemistry
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SPIFE LIPPOROTEIN-12, MODEL 3344 (K022333)Helena Laboratories2002-08-15
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 (K022053)Sebia2002-07-12
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K013662)Quantimetrix Corp.2002-03-08
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 (K012789)Morax2002-01-17
SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (K013466)Helena Laboratories2001-12-21
LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K010337)Quantimetrix Corp.2001-07-25
SPIFE CHOLESTEROL PROFILE KIT (K000603)Helena Laboratories2000-04-17
REP CHOLESTEROL PROFILE KIT (K992971)Helena Laboratories1999-10-18
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 (K974854)Morax1998-10-07
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL (K980650)Helena Laboratories1998-05-01
MACRALP(A) ENZYME IMMUNOASSAY KIT (K971157)Strategic Diagnostics, Inc.1998-04-15
REP 3 QUTO-FLUR CHOLESTEROL-30 (K962914)Helena Laboratories1997-01-13
REP FLUR CHOLESTEROL-60 KIT (K964471)Helena Laboratories1996-12-23
RAPID ELECTROPHORESIS ANALYZER (K960571)Helena Laboratories1996-10-25
LFS LIPOGEL ASSAY KIT (K960785)Zaxis, Inc.1996-09-03
REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT (K935162)Helena Laboratories1994-11-10
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 (K940679)Helena Laboratories1994-09-09
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 (K893223)Helena Laboratories1989-06-09
REP LIPO KIT CAT. NO 3180 (K881809)Helena Laboratories1988-06-01
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM (K871319)Helena Laboratories1987-04-22
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE (K854057)Beckman Instruments, Inc.1985-12-05
TITAN GEL LIPOPROTEIN ELECTROPHORESIS (K833611)Helena Laboratories1984-03-15
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT (K802822)Beckman Instruments, Inc.1980-12-11
GELMAN LIPOPROTEIN FRS SET. P/N 51213 (K791606)Gelman Sciences, Inc.1979-09-17
CHOLESTEROL REAGENT SUBSTRATE SET (K781970)Corning Medical & Scientific1979-01-03
HDL CHOLESTEROL METHOD (K780256)Helena Laboratories1978-03-28

Track JHO automatically

Every clearance here is in the API, with alerts when new ones post.