FDA product code JMX: Ninhydrin, Nitrogen (Amino-Nitrogen)
JMX is the FDA product code for ninhydrin, nitrogen (amino-nitrogen). It is a Class I device, regulated under 21 CFR 862.1515 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JMX, from 2 different applicants. The average 510(k) review took 29 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Ninhydrin, Nitrogen (Amino-Nitrogen) |
| Device class | Class I |
| Regulation | 21 CFR 862.1515 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JMX clearance
Top JMX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biotecx Laboratories, Inc. | 1 | 1986-09-25 |
| Beckman Instruments, Inc. | 1 | 1978-06-13 |
Most recent JMX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863188 | Biotecx Laboratories, Inc. | HPL RIA KIT | 1986-09-25 | 37 |
| K780847 | Beckman Instruments, Inc. | NINHYDRIN REAGENT KIT | 1978-06-13 | 21 |
Recalls for JMX devices
openFDA lists no recalls for product code JMX.
Frequently asked questions
What is FDA product code JMX?
JMX is the FDA product code for ninhydrin, nitrogen (amino-nitrogen). It is a Class I device, regulated under 21 CFR 862.1515 and reviewed by the Clinical Chemistry panel.
What device class is JMX?
Class I, regulation 21 CFR 862.1515. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JMX?
Across 2 cleared submissions the average was 29 days from receipt to decision (median 29).
Which companies have the most JMX clearances?
Biotecx Laboratories, Inc. (1); Beckman Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JMX
- Run a recall and safety report across every JMX manufacturer
- Watch product code JMX 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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