FDA Product Code
FDA Product Code JHO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1475
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 | Helena Laboratories | 2002-08-15 | Traditional | PDF ↗ |
| K022053 | HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 | Sebia | 2002-07-12 | Special | PDF ↗ |
| K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Quantimetrix Corp. | 2002-03-08 | Special | PDF ↗ |
| K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | Morax | 2002-01-17 | Special | PDF ↗ |
| K013466 | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 | Helena Laboratories | 2001-12-21 | Traditional | PDF ↗ |
| K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Quantimetrix Corp. | 2001-07-25 | Traditional | PDF ↗ |
| K000603 | SPIFE CHOLESTEROL PROFILE KIT | Helena Laboratories | 2000-04-17 | Traditional | PDF ↗ |
| K992971 | REP CHOLESTEROL PROFILE KIT | Helena Laboratories | 1999-10-18 | Traditional | PDF ↗ |
| K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 | Morax | 1998-10-07 | Traditional | PDF ↗ |
| K980650 | REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL | Helena Laboratories | 1998-05-01 | Traditional | PDF ↗ |
| K971157 | MACRALP(A) ENZYME IMMUNOASSAY KIT | Strategic Diagnostics, Inc. | 1998-04-15 | Traditional | PDF ↗ |
| K962914 | REP 3 QUTO-FLUR CHOLESTEROL-30 | Helena Laboratories | 1997-01-13 | Traditional | PDF ↗ |
| K964471 | REP FLUR CHOLESTEROL-60 KIT | Helena Laboratories | 1996-12-23 | Traditional | PDF ↗ |
| K960571 | RAPID ELECTROPHORESIS ANALYZER | Helena Laboratories | 1996-10-25 | Traditional | PDF ↗ |
| K960785 | LFS LIPOGEL ASSAY KIT | Zaxis, Inc. | 1996-09-03 | Traditional | PDF ↗ |
| K935162 | REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT | Helena Laboratories | 1994-11-10 | Traditional | PDF ↗ |
| K940679 | REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 | Helena Laboratories | 1994-09-09 | Traditional | PDF ↗ |
| K893223 | REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 | Helena Laboratories | 1989-06-09 | Traditional | PDF ↗ |
| K881809 | REP LIPO KIT CAT. NO 3180 | Helena Laboratories | 1988-06-01 | Traditional | PDF ↗ |
| K871319 | TITAN GEL MULTI-SLOT LIPO-17 SYSTEM | Helena Laboratories | 1987-04-22 | Traditional | PDF ↗ |
| K854057 | PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE | Beckman Instruments, Inc. | 1985-12-05 | Traditional | PDF ↗ |
| K833611 | TITAN GEL LIPOPROTEIN ELECTROPHORESIS | Helena Laboratories | 1984-03-15 | Traditional | PDF ↗ |
| K802822 | PARAGON LIPOPROTEIN ELECTRO. REAG. KIT | Beckman Instruments, Inc. | 1980-12-11 | Traditional | PDF ↗ |
| K791606 | GELMAN LIPOPROTEIN FRS SET. P/N 51213 | Gelman Sciences, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K781970 | CHOLESTEROL REAGENT SUBSTRATE SET | Corning Medical & Scientific | 1979-01-03 | Traditional | PDF ↗ |
| K780256 | HDL CHOLESTEROL METHOD | Helena Laboratories | 1978-03-28 | Traditional | PDF ↗ |
Product code JHO · Class I · Clinical Chemistry. Data: openFDA.