FDA product code JLG: Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
JLG is the FDA product code for conversion to ferric hydroxymates (colorimetric), fatty acids. It is a Class I device, regulated under 21 CFR 862.1290 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JLG, from 2 different applicants. The average 510(k) review took 14 days (median 14). FDA has posted 1 recall for JLG devices.
Classification
| Field | Value |
|---|---|
| Device name | Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids |
| Device class | Class I |
| Regulation | 21 CFR 862.1290 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JLG clearance
Top JLG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wako Chemicals USA, Inc. | 1 | 1981-08-12 |
| Dennison Manufacturing Co. | 1 | 1976-10-08 |
Most recent JLG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812081 | Wako Chemicals USA, Inc. | WAKO NEFA C TEST | 1981-08-12 | 21 |
| K760750 | Dennison Manufacturing Co. | STERILE TUBULAR UNBLEACHED STOCKINETTE | 1976-10-08 | 7 |
Recalls for JLG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-09-23.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code JLG?
JLG is the FDA product code for conversion to ferric hydroxymates (colorimetric), fatty acids. It is a Class I device, regulated under 21 CFR 862.1290 and reviewed by the Clinical Chemistry panel.
What device class is JLG?
Class I, regulation 21 CFR 862.1290. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JLG?
Across 2 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most JLG clearances?
Wako Chemicals USA, Inc. (1); Dennison Manufacturing Co. (1).
Have JLG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-09-23.
Next steps
- Run an FDA pathway report with predicate devices for product code JLG
- Run a recall and safety report across every JLG manufacturer
- Watch product code JLG 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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