FDA product code JGM: Flame Photometry, Potassium
JGM is the FDA product code for flame photometry, potassium. It is a Class II device, regulated under 21 CFR 862.1600 and reviewed by the Clinical Chemistry panel. FDA has cleared 5 510(k) submissions under JGM, from 5 different applicants. The average 510(k) review took 39 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Flame Photometry, Potassium |
| Device class | Class II |
| Regulation | 21 CFR 862.1600 |
| 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 JGM clearance
Top JGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Data Medical Associates, Inc. | 1 | 1989-10-19 |
| Amresco, Inc. | 1 | 1986-07-29 |
| Medical Specialties, Inc. | 1 | 1983-07-18 |
| Mallinckrodt Critical Care | 1 | 1981-02-10 |
| Environmental Chemical Specialties | 1 | 1977-07-12 |
Most recent JGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895718 | Data Medical Associates, Inc. | LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER | 1989-10-19 | 24 |
| K862300 | Amresco, Inc. | AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT | 1986-07-29 | 42 |
| K831300 | Medical Specialties, Inc. | MSI-NAK-50 TEST KIT | 1983-07-18 | 88 |
| K810253 | Mallinckrodt Critical Care | SODIUM & POTASSIUM TEST KIT | 1981-02-10 | 11 |
| K771068 | Environmental Chemical Specialties | TRIGLYCERIDE KIT | 1977-07-12 | 29 |
Recalls for JGM devices
openFDA lists no recalls for product code JGM.
Frequently asked questions
What is FDA product code JGM?
JGM is the FDA product code for flame photometry, potassium. It is a Class II device, regulated under 21 CFR 862.1600 and reviewed by the Clinical Chemistry panel.
What device class is JGM?
Class II, regulation 21 CFR 862.1600. Typical premarket route: 510(k).
How long does a 510(k) take for product code JGM?
Across 5 cleared submissions the average was 39 days from receipt to decision (median 29).
Which companies have the most JGM clearances?
Data Medical Associates, Inc. (1); Amresco, Inc. (1); Medical Specialties, Inc. (1); Mallinckrodt Critical Care (1); Environmental Chemical Specialties (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JGM
- Run a recall and safety report across every JGM manufacturer
- Watch product code JGM 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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