Panels › Clinical Chemistry › Product code JHO · Class 1
Electrophoretic Separation, Lipoproteins
Regulation 862.1475
0510(k)s in 12 months (26 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JHO
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 15 | 0 |
| Beckman Instruments, Inc. | 2 | 0 |
| Morax | 2 | 0 |
| Quantimetrix Corp. | 2 | 0 |
| Corning Medical & Scientific | 1 | 0 |
| Gelman Sciences, Inc. | 1 | 0 |
| Sebia | 1 | 0 |
| Strategic Diagnostics, Inc. | 1 | 0 |
| Zaxis, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 15, 2002 | K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 Helena Laboratories | JHO |
| Jul 12, 2002 | K022053 | HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 Sebia | JHO |
| Mar 8, 2002 | K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS Quantimetrix Corp. | JHO |
| Jan 17, 2002 | K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 Morax | JHO |
| Dec 21, 2001 | K013466 | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 Helena Laboratories | JHO |
| Jul 25, 2001 | K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS Quantimetrix Corp. | JHO |
| Apr 17, 2000 | K000603 | SPIFE CHOLESTEROL PROFILE KIT Helena Laboratories | JHO |
| Oct 18, 1999 | K992971 | REP CHOLESTEROL PROFILE KIT Helena Laboratories | JHO |
| Oct 7, 1998 | K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 Morax | JHO |
| May 1, 1998 | K980650 | REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL Helena Laboratories | JHO |
| Apr 15, 1998 | K971157 | MACRALP(A) ENZYME IMMUNOASSAY KIT Strategic Diagnostics, Inc. | JHO |
| Jan 13, 1997 | K962914 | REP 3 QUTO-FLUR CHOLESTEROL-30 Helena Laboratories | JHO |
| Dec 23, 1996 | K964471 | REP FLUR CHOLESTEROL-60 KIT Helena Laboratories | JHO |
| Oct 25, 1996 | K960571 | RAPID ELECTROPHORESIS ANALYZER Helena Laboratories | JHO |
| Sep 3, 1996 | K960785 | LFS LIPOGEL ASSAY KIT Zaxis, Inc. | JHO |
| Nov 10, 1994 | K935162 | REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT Helena Laboratories | JHO |
| Sep 9, 1994 | K940679 | REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 Helena Laboratories | JHO |
| Jun 9, 1989 | K893223 | REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 Helena Laboratories | JHO |
| Jun 1, 1988 | K881809 | REP LIPO KIT CAT. NO 3180 Helena Laboratories | JHO |
| Apr 22, 1987 | K871319 | TITAN GEL MULTI-SLOT LIPO-17 SYSTEM Helena Laboratories | JHO |
| Dec 5, 1985 | K854057 | PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE Beckman Instruments, Inc. | JHO |
| Mar 15, 1984 | K833611 | TITAN GEL LIPOPROTEIN ELECTROPHORESIS Helena Laboratories | JHO |
| Dec 11, 1980 | K802822 | PARAGON LIPOPROTEIN ELECTRO. REAG. KIT Beckman Instruments, Inc. | JHO |
| Sep 17, 1979 | K791606 | GELMAN LIPOPROTEIN FRS SET. P/N 51213 Gelman Sciences, Inc. | JHO |
| Jan 3, 1979 | K781970 | CHOLESTEROL REAGENT SUBSTRATE SET Corning Medical & Scientific | JHO |
| Mar 28, 1978 | K780256 | HDL CHOLESTEROL METHOD Helena Laboratories | JHO |
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