JHO · Class I · 21 CFR 862.1475

FDA Product Code JHO: Electrophoretic Separation, Lipoproteins

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

26
Total
26
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
K022333
Helena Laboratories
Chemistry · 28d
Cleared Dec 21, 2001
SPIFE 2000/3000 LIPOPROTEIN
K013466
Helena Laboratories
Chemistry · 64d
Cleared Apr 17, 2000
SPIFE CHOLESTEROL PROFILE KIT
K000603
Helena Laboratories
Chemistry · 54d
Cleared Oct 18, 1999
REP CHOLESTEROL PROFILE KIT
K992971
Helena Laboratories
Chemistry · 45d
Cleared May 01, 1998
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8
K980650
Helena Laboratories
Chemistry · 71d
Cleared Jan 13, 1997
REP 3 QUTO-FLUR CHOLESTEROL-30
K962914
Helena Laboratories
Chemistry · 171d
Cleared Dec 23, 1996
REP FLUR CHOLESTEROL-60 KIT
K964471
Helena Laboratories
Chemistry · 46d
Cleared Oct 25, 1996
RAPID ELECTROPHORESIS ANALYZER
K960571
Helena Laboratories
Chemistry · 260d
Cleared Nov 10, 1994
REP DIRECT-SEP CHOLESTEROL-15 KIT
K935162
Helena Laboratories
Chemistry · 377d
Cleared Sep 09, 1994
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222
K940679
Helena Laboratories
Chemistry · 212d
Cleared Jun 09, 1989
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181
K893223
Helena Laboratories
Chemistry · 43d
Cleared Jun 01, 1988
REP LIPO KIT CAT. NO 3180
K881809
Helena Laboratories
Chemistry · 34d
Cleared Apr 22, 1987
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM
K871319
Helena Laboratories
Chemistry · 19d
Cleared Dec 05, 1985
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE
K854057
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Mar 15, 1984
TITAN GEL LIPOPROTEIN ELECTROPHORESIS
K833611
Helena Laboratories
Chemistry · 154d
Cleared Dec 11, 1980
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT
K802822
Beckman Instruments, Inc.
Immunology · 31d
Cleared Mar 28, 1978
HDL CHOLESTEROL METHOD
K780256
Helena Laboratories
Chemistry · 43d

About Product Code JHO - Regulatory Context