FDA product code JHF: Colorimetric Method, Lecithin/Sphingomyelin Ratio
JHF is the FDA product code for colorimetric method, 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 2 510(k) submissions under JHF, from 2 different applicants. The average 510(k) review took 282 days (median 282).
Classification
| Field | Value |
|---|---|
| Device name | Colorimetric Method, 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 JHF clearance
Top JHF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 1 | 1995-02-08 |
| Isolab, Inc. | 1 | 1989-03-15 |
Most recent JHF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940817 | Abbott Laboratories | TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II | 1995-02-08 | 351 |
| K883411 | Isolab, Inc. | PG-NUMERIC(TM) | 1989-03-15 | 212 |
Recalls for JHF devices
openFDA lists no recalls for product code JHF.
Frequently asked questions
What is FDA product code JHF?
JHF is the FDA product code for colorimetric method, 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 JHF?
Class II, regulation 21 CFR 862.1455. Typical premarket route: 510(k).
How long does a 510(k) take for product code JHF?
Across 2 cleared submissions the average was 282 days from receipt to decision (median 282).
Which companies have the most JHF clearances?
Abbott Laboratories (1); Isolab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JHF
- Run a recall and safety report across every JHF manufacturer
- Watch product code JHF 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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