Product code JHO
- Device name
- Electrophoretic Separation, Lipoproteins
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1475
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 | Helena Laboratories | 2002-08-15 |
| K022053 | HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 | Sebia | 2002-07-12 |
| K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Quantimetrix Corp. | 2002-03-08 |
| K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | Morax | 2002-01-17 |
| K013466 | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 | Helena Laboratories | 2001-12-21 |
| K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | Quantimetrix Corp. | 2001-07-25 |
| K000603 | SPIFE CHOLESTEROL PROFILE KIT | Helena Laboratories | 2000-04-17 |
| K992971 | REP CHOLESTEROL PROFILE KIT | Helena Laboratories | 1999-10-18 |
| K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 | Morax | 1998-10-07 |
| K980650 | REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL | Helena Laboratories | 1998-05-01 |
| K971157 | MACRALP(A) ENZYME IMMUNOASSAY KIT | Strategic Diagnostics, Inc. | 1998-04-15 |
| K962914 | REP 3 QUTO-FLUR CHOLESTEROL-30 | Helena Laboratories | 1997-01-13 |
| K964471 | REP FLUR CHOLESTEROL-60 KIT | Helena Laboratories | 1996-12-23 |
| K960571 | RAPID ELECTROPHORESIS ANALYZER | Helena Laboratories | 1996-10-25 |
| K960785 | LFS LIPOGEL ASSAY KIT | Zaxis, Inc. | 1996-09-03 |
| K935162 | REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT | Helena Laboratories | 1994-11-10 |
| K940679 | REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 | Helena Laboratories | 1994-09-09 |
| K893223 | REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 | Helena Laboratories | 1989-06-09 |
| K881809 | REP LIPO KIT CAT. NO 3180 | Helena Laboratories | 1988-06-01 |
| K871319 | TITAN GEL MULTI-SLOT LIPO-17 SYSTEM | Helena Laboratories | 1987-04-22 |
| K854057 | PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE | Beckman Instruments, Inc. | 1985-12-05 |
| K833611 | TITAN GEL LIPOPROTEIN ELECTROPHORESIS | Helena Laboratories | 1984-03-15 |
| K802822 | PARAGON LIPOPROTEIN ELECTRO. REAG. KIT | Beckman Instruments, Inc. | 1980-12-11 |
| K791606 | GELMAN LIPOPROTEIN FRS SET. P/N 51213 | Gelman Sciences, Inc. | 1979-09-17 |
| K781970 | CHOLESTEROL REAGENT SUBSTRATE SET | Corning Medical & Scientific | 1979-01-03 |
| K780256 | HDL CHOLESTEROL METHOD | Helena Laboratories | 1978-03-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03607360041444 | HYDRAGEL 30 LIPO + Lp(a) | SEBIA | 2022-12-12 |
| 03607360041390 | HYDRAGEL 30 LDL/HDL CHOL DIRECT | SEBIA | 2022-12-12 |
| 03607360041352 | HYDRAGEL 15 LDL/HDL CHOL DIRECT | SEBIA | 2022-12-12 |
| 03607360041246 | HYDRAGEL 15 LIPO + Lp(a) | SEBIA | 2022-12-12 |
| 03607360041161 | HYDRAGEL 7 LDL/HDL CHOL DIRECT | SEBIA | 2022-12-12 |
| 03607360041147 | HYDRAGEL 7 LIPOPROTEIN(E) | SEBIA | 2022-12-12 |
| 03607360041048 | HYDRAGEL 7 LIPO + Lp(a) | SEBIA | 2022-12-12 |
| 03607360030073 | HYDRAGEL LIPO + Lp(a) K20 | SEBIA | 2022-12-12 |
| 00896863002332 | Lipoprint LDL Subfractions Kit 4x25 tests | QUANTIMETRIX CORPORATION | 2018-09-26 |
| 00896863002318 | Liposure Serum Lipoprotein Control Level 1 4x0.5mL | QUANTIMETRIX CORPORATION | 2018-09-26 |
| 00896863002325 | Lipoprint System Buffer 4x16.5g | QUANTIMETRIX CORPORATION | 2018-09-26 |
| M52550450 | Coolant Sponges (10/pkg) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255526140 | SPIFE Vis Cholesterol Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255526080 | SPIFE Lipoprotein Gel Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255523630 | QUICKGEL Lipoprotein Gel Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255520030 | QUICKGEL Cholesterol Gel Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255519910 | SPIFE Lipoprotein Gel Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255519410 | SPIFE Vis Cholesterol Reagent Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M5255519190 | SPIFE Vis Cholesterol Kit | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52553220 | Lipoprotein Stain (1 x 2.8 g Powder) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| M52539000 | Titan III Lipo (60 x 76 mm) | HELENA LABORATORIES CORPORATION | 2017-03-17 |
| 05391516743938 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |