JHO — Electrophoretic Separation, Lipoproteins Class I
FDA product code JHO covers "Electrophoretic Separation, Lipoproteins", a Class I medical device regulated under 21 CFR 862.1475. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JHO
- Device Class
- Class I
- Regulation Number
- 862.1475
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K022333 | helena laboratories | SPIFE LIPPOROTEIN-12, MODEL 3344 | August 15, 2002 |
| K022053 | sebia | HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 | July 12, 2002 |
| K013662 | quantimetrix | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | March 8, 2002 |
| K012789 | morax | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | January 17, 2002 |
| K013466 | helena laboratories | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 | December 21, 2001 |
| K010337 | quantimetrix | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | July 25, 2001 |
| K000603 | helena laboratories | SPIFE CHOLESTEROL PROFILE KIT | April 17, 2000 |
| K992971 | helena laboratories | REP CHOLESTEROL PROFILE KIT | October 18, 1999 |
| K974854 | morax | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KI | October 7, 1998 |
| K980650 | helena laboratories | REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL | May 1, 1998 |
| K971157 | strategic diagnostics | MACRALP(A) ENZYME IMMUNOASSAY KIT | April 15, 1998 |
| K962914 | helena laboratories | REP 3 QUTO-FLUR CHOLESTEROL-30 | January 13, 1997 |
| K964471 | helena laboratories | REP FLUR CHOLESTEROL-60 KIT | December 23, 1996 |
| K960571 | helena laboratories | RAPID ELECTROPHORESIS ANALYZER | October 25, 1996 |
| K960785 | zaxis | LFS LIPOGEL ASSAY KIT | September 3, 1996 |
| K935162 | helena laboratories | REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT | November 10, 1994 |
| K940679 | helena laboratories | REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 | September 9, 1994 |
| K893223 | helena laboratories | REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 | June 9, 1989 |
| K881809 | helena laboratories | REP LIPO KIT CAT. NO 3180 | June 1, 1988 |
| K871319 | helena laboratories | TITAN GEL MULTI-SLOT LIPO-17 SYSTEM | April 22, 1987 |