FDA product code JMA: Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
JMA is the FDA product code for acid, ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric). It is a Class I device, regulated under 21 CFR 862.1095 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under JMA, from 3 different applicants. The average 510(k) review took 93 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) |
| Device class | Class I |
| Regulation | 21 CFR 862.1095 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JMA clearance
Top JMA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quantimetrix Corp. | 1 | 1993-06-25 |
| Helena Laboratories | 1 | 1983-05-13 |
| Laprol Scientific, Inc. | 1 | 1983-01-28 |
Most recent JMA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931523 | Quantimetrix Corp. | QUANTIMETRIX C-CLEAR(TM) | 1993-06-25 | 91 |
| K830978 | Helena Laboratories | HELENA BIOSTRIP A | 1983-05-13 | 45 |
| K822709 | Laprol Scientific, Inc. | URITEST 9, INLAB REAGENT STRIPS URINALY | 1983-01-28 | 143 |
Recalls for JMA devices
openFDA lists no recalls for product code JMA.
Frequently asked questions
What is FDA product code JMA?
JMA is the FDA product code for acid, ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric). It is a Class I device, regulated under 21 CFR 862.1095 and reviewed by the Clinical Chemistry panel.
What device class is JMA?
Class I, regulation 21 CFR 862.1095. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JMA?
Across 3 cleared submissions the average was 93 days from receipt to decision (median 91).
Which companies have the most JMA clearances?
Quantimetrix Corp. (1); Helena Laboratories (1); Laprol Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JMA
- Run a recall and safety report across every JMA manufacturer
- Watch product code JMA 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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