FDA product code JHG: Chromatographic Separation, Lecithin/Sphingomyelin Ratio
JHG is the FDA product code for chromatographic separation, lecithin/sphingomyelin ratio. It is a Class II device, regulated under 21 CFR 862.1455 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under JHG, from 5 different applicants. The average 510(k) review took 83 days (median 87).
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic Separation, Lecithin/Sphingomyelin Ratio |
| Device class | Class II |
| Regulation | 21 CFR 862.1455 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JHG clearance
Top JHG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hana Biologics, Inc. | 2 | 1984-05-25 |
| Helena Laboratories | 2 | 1981-06-25 |
| Irvine Scientific Sales Co., Inc. | 1 | 2006-10-18 |
| Abbott Laboratories | 1 | 1987-07-20 |
| Beckman Instruments, Inc. | 1 | 1981-12-17 |
Most recent JHG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061549 | Irvine Scientific Sales Co., Inc. | AMNIOSTAT-FLM-PG | 2006-10-18 | 135 |
| K871593 | Abbott Laboratories | TDXR FETAL LUNG MATURITY | 1987-07-20 | 87 |
| K834616 | Hana Biologics, Inc. | AMNIO STAT-FLM AGGLUTINATION TEST | 1984-05-25 | 163 |
| K822150 | Hana Biologics, Inc. | AMNISTAT-FLM | 1982-10-21 | 91 |
| K813216 | Beckman Instruments, Inc. | SECURE FDI TEST KIT | 1981-12-17 | 38 |
Recalls for JHG devices
openFDA lists no recalls for product code JHG.
Frequently asked questions
What is FDA product code JHG?
JHG is the FDA product code for chromatographic separation, lecithin/sphingomyelin ratio. It is a Class II device, regulated under 21 CFR 862.1455 and reviewed by the Clinical Chemistry panel.
What device class is JHG?
Class II, regulation 21 CFR 862.1455. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHG?
Across 7 cleared submissions the average was 83 days from receipt to decision (median 87).
Which companies have the most JHG clearances?
Hana Biologics, Inc. (2); Helena Laboratories (2); Irvine Scientific Sales Co., Inc. (1); Abbott Laboratories (1); Beckman Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JHG
- Run a recall and safety report across every JHG manufacturer
- Watch product code JHG 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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