FDA product code JKP: Chromium-51, Blood Volume
JKP is the FDA product code for chromium-51, blood volume. It is a Class I device, regulated under 21 CFR 862.1130 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JKP. The average 510(k) review took 11 days (median 11).
Classification
| Field | Value |
|---|---|
| Device name | Chromium-51, Blood Volume |
| Device class | Class I |
| Regulation | 21 CFR 862.1130 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JKP clearance
Top JKP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Analytical Products, Inc. | 1 | 1981-04-03 |
Most recent JKP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810762 | Analytical Products, Inc. | API TURBICITY STANDARD | 1981-04-03 | 11 |
Recalls for JKP devices
openFDA lists no recalls for product code JKP.
Frequently asked questions
What is FDA product code JKP?
JKP is the FDA product code for chromium-51, blood volume. It is a Class I device, regulated under 21 CFR 862.1130 and reviewed by the Clinical Chemistry panel.
What device class is JKP?
Class I, regulation 21 CFR 862.1130. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKP?
Across 1 cleared submissions the average was 11 days from receipt to decision (median 11).
Which companies have the most JKP clearances?
Analytical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JKP
- Run a recall and safety report across every JKP manufacturer
- Watch product code JKP 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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