FDA product code JHO: Electrophoretic Separation, Lipoproteins
JHO is the FDA product code for electrophoretic separation, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 26 510(k) submissions under JHO, from 9 different applicants. The average 510(k) review took 119 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Electrophoretic Separation, Lipoproteins |
| Device class | Class I |
| Regulation | 21 CFR 862.1475 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JHO clearance
Top JHO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 15 | 2002-08-15 |
| Quantimetrix Corp. | 2 | 2002-03-08 |
| Morax | 2 | 2002-01-17 |
| Beckman Instruments, Inc. | 2 | 1985-12-05 |
| Sebia | 1 | 2002-07-12 |
4 more applicants have JHO clearances. See the full list in Caduvo.
Most recent JHO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022333 | Helena Laboratories | SPIFE LIPPOROTEIN-12, MODEL 3344 | 2002-08-15 | 28 |
| K022053 | Sebia | HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 | 2002-07-12 | 18 |
| K013662 | Quantimetrix Corp. | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | 2002-03-08 | 122 |
| K012789 | Morax | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | 2002-01-17 | 150 |
| K013466 | Helena Laboratories | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 | 2001-12-21 | 64 |
Recalls for JHO devices
openFDA lists no recalls for product code JHO.
Frequently asked questions
What is FDA product code JHO?
JHO is the FDA product code for electrophoretic separation, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is JHO?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JHO?
Across 26 cleared submissions the average was 119 days from receipt to decision (median 64).
Which companies have the most JHO clearances?
Helena Laboratories (15); Quantimetrix Corp. (2); Morax (2); Beckman Instruments, Inc. (2); Sebia (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JHO
- Run a recall and safety report across every JHO manufacturer
- Watch product code JHO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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