510(k) K022053
- Device
- HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
- Applicant
- Sebia
- 510(k) number
- K022053
- Product code
- JHO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-12
- Date received
- 2002-06-24
- Regulation
- 862.1475
- Classification name
- Electrophoretic Separation, Lipoproteins
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- BOREK JANIK
- Address
- 13805 Waterloo Chelsea MI US 48118 48118
FDA Registration Numbers#
- 8023024
- 1618982
- 2020715
- 1318354
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JHO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 | Helena Laboratories | 2002-08-15 |
| 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 |