FDA product code JMD: Radioimmunoassay, Total Estrogens, Nonpregnancy
JMD is the FDA product code for radioimmunoassay, total estrogens, nonpregnancy. It is a Class I device, regulated under 21 CFR 862.1275 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JMD, from 2 different applicants. The average 510(k) review took 38 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Total Estrogens, Nonpregnancy |
| Device class | Class I |
| Regulation | 21 CFR 862.1275 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JMD clearance
Top JMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radioassay Systems Laboratories, Inc. | 1 | 1979-09-27 |
| Environmental Sciences Assoc., Inc. | 1 | 1978-07-27 |
Most recent JMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791651 | Radioassay Systems Laboratories, Inc. | TOTAL ESTROGENS KIT BY RIA | 1979-09-27 | 37 |
| K781009 | Environmental Sciences Assoc., Inc. | ANALYZER, SERUM IRON & TOTAL IRON BINDIN | 1978-07-27 | 38 |
Recalls for JMD devices
openFDA lists no recalls for product code JMD.
Frequently asked questions
What is FDA product code JMD?
JMD is the FDA product code for radioimmunoassay, total estrogens, nonpregnancy. It is a Class I device, regulated under 21 CFR 862.1275 and reviewed by the Clinical Chemistry panel.
What device class is JMD?
Class I, regulation 21 CFR 862.1275. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JMD?
Across 2 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most JMD clearances?
Radioassay Systems Laboratories, Inc. (1); Environmental Sciences Assoc., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JMD
- Run a recall and safety report across every JMD manufacturer
- Watch product code JMD 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times