FDA product code JKJ: Fluorometric Measurement, Porphyrins
JKJ is the FDA product code for fluorometric measurement, porphyrins. It is a Class I device, regulated under 21 CFR 862.1595 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under JKJ, from 2 different applicants. The average 510(k) review took 156 days (median 131).
Classification
| Field | Value |
|---|---|
| Device name | Fluorometric Measurement, Porphyrins |
| Device class | Class I |
| Regulation | 21 CFR 862.1595 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top JKJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 2 | 1989-11-17 |
| Whale Scientific, Inc. | 1 | 1978-07-27 |
Most recent JKJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893038 | Helena Laboratories | PROTOFLUOR Z | 1989-11-17 | 207 |
| K871499 | Helena Laboratories | PROTOFLUOR Z | 1987-08-25 | 131 |
| K780455 | Whale Scientific, Inc. | QUANTITATIVE DETERMINATION OF PORPHYRINS | 1978-07-27 | 129 |
Recalls for JKJ devices
openFDA lists no recalls for product code JKJ.
Frequently asked questions
What is FDA product code JKJ?
JKJ is the FDA product code for fluorometric measurement, porphyrins. It is a Class I device, regulated under 21 CFR 862.1595 and reviewed by the Clinical Chemistry panel.
What device class is JKJ?
Class I, regulation 21 CFR 862.1595. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKJ?
Across 3 cleared submissions the average was 156 days from receipt to decision (median 131).
Which companies have the most JKJ clearances?
Helena Laboratories (2); Whale Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JKJ
- Run a recall and safety report across every JKJ manufacturer
- Watch product code JKJ 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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