FDA product code JGW: Fluorometric Method, Triglycerides
JGW is the FDA product code for fluorometric method, triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under JGW, from 3 different applicants. The average 510(k) review took 29 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Fluorometric Method, Triglycerides |
| Device class | Class I |
| Regulation | 21 CFR 862.1705 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JGW clearance
Top JGW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Chemical Co. | 1 | 1987-08-17 |
| Abbott Laboratories | 1 | 1985-07-22 |
| Boehringer Mannheim Corp. | 1 | 1978-04-18 |
Most recent JGW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872912 | Sigma Chemical Co. | TRIGLYCERIDE (UV) REAGENT | 1987-08-17 | 24 |
| K852556 | Abbott Laboratories | TDX REA TRIGLYCERIDES | 1985-07-22 | 35 |
| K780439 | Boehringer Mannheim Corp. | PRECIMAT GLYCEROL | 1978-04-18 | 29 |
Recalls for JGW devices
openFDA lists no recalls for product code JGW.
Frequently asked questions
What is FDA product code JGW?
JGW is the FDA product code for fluorometric method, triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel.
What device class is JGW?
Class I, regulation 21 CFR 862.1705. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JGW?
Across 3 cleared submissions the average was 29 days from receipt to decision (median 29).
Which companies have the most JGW clearances?
Sigma Chemical Co. (1); Abbott Laboratories (1); Boehringer Mannheim Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JGW
- Run a recall and safety report across every JGW manufacturer
- Watch product code JGW 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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