FDA product code JGF: Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
JGF is the FDA product code for differential rate kinetic method, lactate dehydrogenase isoenzymes. It is a Class II device, regulated under 21 CFR 862.1445 and reviewed by the Clinical Chemistry panel. FDA has cleared 6 510(k) submissions under JGF, from 4 different applicants. The average 510(k) review took 61 days (median 57).
Classification
| Field | Value |
|---|---|
| Device name | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1445 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JGF clearance
Top JGF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 2 | 1998-05-18 |
| Em Diagnostic Systems, Inc. | 2 | 1993-02-05 |
| Trace Scientific , Ltd. | 1 | 1989-05-05 |
| Alpkem Corp. | 1 | 1986-04-11 |
Most recent JGF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K981338 | Abbott Laboratories | LD-1 | 1998-05-18 | 35 |
| K925188 | Em Diagnostic Systems, Inc. | ABBOTT QUICKSTART LD-1, MODIFICATION | 1993-02-05 | 120 |
| K914261 | Em Diagnostic Systems, Inc. | ABBOTT QUICKSTART LD-1,#5A30 | 1991-10-21 | 28 |
| K890996 | Trace Scientific , Ltd. | LD1 ISOENZYME REAGENT KIT | 1989-05-05 | 67 |
| K871240 | Abbott Laboratories | ABBOTT A-GENT LD-1 ISOZYME REAGENT | 1987-05-13 | 47 |
Recalls for JGF devices
openFDA lists no recalls for product code JGF.
Frequently asked questions
What is FDA product code JGF?
JGF is the FDA product code for differential rate kinetic method, lactate dehydrogenase isoenzymes. It is a Class II device, regulated under 21 CFR 862.1445 and reviewed by the Clinical Chemistry panel.
What device class is JGF?
Class II, regulation 21 CFR 862.1445. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JGF?
Across 6 cleared submissions the average was 61 days from receipt to decision (median 57).
Which companies have the most JGF clearances?
Abbott Laboratories (2); Em Diagnostic Systems, Inc. (2); Trace Scientific , Ltd. (1); Alpkem Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JGF
- Run a recall and safety report across every JGF manufacturer
- Watch product code JGF 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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