FDA product code JKL: Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
JKL is the FDA product code for acid, delta-aminolevulinic, ion-exchange columns with colorimetry. It is a Class I device, regulated under 21 CFR 862.1060 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JKL, from 2 different applicants. The average 510(k) review took 71 days (median 71).
Classification
| Field | Value |
|---|---|
| Device name | Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry |
| Device class | Class I |
| Regulation | 21 CFR 862.1060 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JKL clearance
Top JKL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 1 | 1992-05-26 |
| Hml Inc/Biotechnology Transfer | 1 | 1984-09-06 |
Most recent JKL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921534 | Diagnostic Systems Laboratories, Inc. | DSL DHEA (DSL 8900) | 1992-05-26 | 56 |
| K842310 | Hml Inc/Biotechnology Transfer | HEMATOLOGY ANALYZER | 1984-09-06 | 86 |
Recalls for JKL devices
openFDA lists no recalls for product code JKL.
Frequently asked questions
What is FDA product code JKL?
JKL is the FDA product code for acid, delta-aminolevulinic, ion-exchange columns with colorimetry. It is a Class I device, regulated under 21 CFR 862.1060 and reviewed by the Clinical Chemistry panel.
What device class is JKL?
Class I, regulation 21 CFR 862.1060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKL?
Across 2 cleared submissions the average was 71 days from receipt to decision (median 71).
Which companies have the most JKL clearances?
Diagnostic Systems Laboratories, Inc. (1); Hml Inc/Biotechnology Transfer (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JKL
- Run a recall and safety report across every JKL manufacturer
- Watch product code JKL 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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