FDA product code JME: Radioimmunoassay, Glucagon
JME is the FDA product code for radioimmunoassay, glucagon. It is a Class I device, regulated under 21 CFR 862.1335 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under JME, from 3 different applicants. The average 510(k) review took 101 days (median 95).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Glucagon |
| Device class | Class I |
| Regulation | 21 CFR 862.1335 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JME clearance
Top JME applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 1 | 1989-10-31 |
| Serono Laboratories, Inc. | 1 | 1979-02-22 |
| Inter Science Institute | 1 | 1978-01-20 |
Most recent JME clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893975 | Diagnostic Products Corp. | DOUBLE ANTIBODY GLUCAGON | 1989-10-31 | 151 |
| K782143 | Serono Laboratories, Inc. | RIA KIT, GLUCOSE | 1979-02-22 | 57 |
| K771948 | Inter Science Institute | GLUCAGON RIA MODULE | 1978-01-20 | 95 |
Recalls for JME devices
openFDA lists no recalls for product code JME.
Frequently asked questions
What is FDA product code JME?
JME is the FDA product code for radioimmunoassay, glucagon. It is a Class I device, regulated under 21 CFR 862.1335 and reviewed by the Clinical Chemistry panel.
What device class is JME?
Class I, regulation 21 CFR 862.1335. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JME?
Across 3 cleared submissions the average was 101 days from receipt to decision (median 95).
Which companies have the most JME clearances?
Diagnostic Products Corp. (1); Serono Laboratories, Inc. (1); Inter Science Institute (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JME
- Run a recall and safety report across every JME manufacturer
- Watch product code JME 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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