FDA product code JKB: Radioimmunoassay, Compound S (11-Deoxycortisol)
JKB is the FDA product code for radioimmunoassay, compound s (11-deoxycortisol). It is a Class I device, regulated under 21 CFR 862.1185 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JKB. The average 510(k) review took 17 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Compound S (11-Deoxycortisol) |
| Device class | Class I |
| Regulation | 21 CFR 862.1185 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JKB clearance
Top JKB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radioassay Systems Laboratories, Inc. | 1 | 1979-09-27 |
Most recent JKB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791740 | Radioassay Systems Laboratories, Inc. | SERUM 11-DESOXYCORTISOL I AS TRACER | 1979-09-27 | 17 |
Recalls for JKB devices
openFDA lists no recalls for product code JKB.
Frequently asked questions
What is FDA product code JKB?
JKB is the FDA product code for radioimmunoassay, compound s (11-deoxycortisol). It is a Class I device, regulated under 21 CFR 862.1185 and reviewed by the Clinical Chemistry panel.
What device class is JKB?
Class I, regulation 21 CFR 862.1185. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKB?
Across 1 cleared submissions the average was 17 days from receipt to decision (median 17).
Which companies have the most JKB clearances?
Radioassay Systems Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JKB
- Run a recall and safety report across every JKB manufacturer
- Watch product code JKB 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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