FDA product code JGT: Flame Photometry, Sodium
JGT is the FDA product code for flame photometry, sodium. It is a Class II device, regulated under 21 CFR 862.1665 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under JGT, from 8 different applicants. The average 510(k) review took 62 days (median 67).
Classification
| Field | Value |
|---|---|
| Device name | Flame Photometry, Sodium |
| Device class | Class II |
| Regulation | 21 CFR 862.1665 |
| 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 JGT clearance
Top JGT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Technicon Instruments Corp. | 1 | 1990-02-23 |
| Em Diagnostic Systems, Inc. | 1 | 1989-06-09 |
| Shaban Mfg. Co. | 1 | 1984-05-25 |
| Sclavo, Inc. | 1 | 1984-03-19 |
| American Monitor Corp. | 1 | 1984-01-30 |
3 more applicants have JGT clearances. See the full list in Caduvo.
Most recent JGT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896829 | Technicon Instruments Corp. | TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) | 1990-02-23 | 81 |
| K891574 | Em Diagnostic Systems, Inc. | LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 | 1989-06-09 | 81 |
| K841610 | Shaban Mfg. Co. | COMPONENTS FOR POTASSIUM, SODIUM CHLO | 1984-05-25 | 46 |
| K840216 | Sclavo, Inc. | SODIUM/POTASSIUM REAGENT SYS | 1984-03-19 | 60 |
| K834248 | American Monitor Corp. | PARALLEL FLAME PHOTOMETER & SODIUM | 1984-01-30 | 54 |
Recalls for JGT devices
openFDA lists no recalls for product code JGT.
Frequently asked questions
What is FDA product code JGT?
JGT is the FDA product code for flame photometry, sodium. It is a Class II device, regulated under 21 CFR 862.1665 and reviewed by the Clinical Chemistry panel.
What device class is JGT?
Class II, regulation 21 CFR 862.1665. Typical premarket route: 510(k).
How long does a 510(k) take for product code JGT?
Across 8 cleared submissions the average was 62 days from receipt to decision (median 67).
Which companies have the most JGT clearances?
Technicon Instruments Corp. (1); Em Diagnostic Systems, Inc. (1); Shaban Mfg. Co. (1); Sclavo, Inc. (1); American Monitor Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JGT
- Run a recall and safety report across every JGT manufacturer
- Watch product code JGT 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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