FDA product code JGG: L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
JGG is the FDA product code for l-leucine-4-nitroanilide (colorimetric), leucine arylamidase. It is a Class I device, regulated under 21 CFR 862.1460 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JGG, from 2 different applicants. The average 510(k) review took 67 days (median 67).
Classification
| Field | Value |
|---|---|
| Device name | L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase |
| Device class | Class I |
| Regulation | 21 CFR 862.1460 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JGG clearance
Top JGG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 1 | 1989-12-05 |
| Alladin Diagnostic, Inc. | 1 | 1985-03-05 |
Most recent JGG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895850 | Beckman Instruments, Inc. | SYNCHRON CX SYSTEMS (LAP) REAGENT KIT | 1989-12-05 | 63 |
| K844965 | Alladin Diagnostic, Inc. | LEUCINE AMINOPEPTIDASE REAGENT | 1985-03-05 | 71 |
Recalls for JGG devices
openFDA lists no recalls for product code JGG.
Frequently asked questions
What is FDA product code JGG?
JGG is the FDA product code for l-leucine-4-nitroanilide (colorimetric), leucine arylamidase. It is a Class I device, regulated under 21 CFR 862.1460 and reviewed by the Clinical Chemistry panel.
What device class is JGG?
Class I, regulation 21 CFR 862.1460. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JGG?
Across 2 cleared submissions the average was 67 days from receipt to decision (median 67).
Which companies have the most JGG clearances?
Beckman Instruments, Inc. (1); Alladin Diagnostic, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JGG
- Run a recall and safety report across every JGG manufacturer
- Watch product code JGG 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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