FDA product code JKT: Gas Chromatograph, Carbon-Monoxide
JKT is the FDA product code for gas chromatograph, carbon-monoxide. It is a Class I device, regulated under 21 CFR 862.3220 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under JKT, from 2 different applicants. The average 510(k) review took 50 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatograph, Carbon-Monoxide |
| Device class | Class I |
| Regulation | 21 CFR 862.3220 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JKT clearance
Top JKT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rna Medical Corp. | 1 | 1983-04-28 |
| Shaban Mfg. Co. | 1 | 1983-01-28 |
Most recent JKT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830843 | Rna Medical Corp. | BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- | 1983-04-28 | 42 |
| K823535 | Shaban Mfg. Co. | DILUENT, ZEROING SOLUTION & CO-OX/ISE | 1983-01-28 | 59 |
Recalls for JKT devices
openFDA lists no recalls for product code JKT.
Frequently asked questions
What is FDA product code JKT?
JKT is the FDA product code for gas chromatograph, carbon-monoxide. It is a Class I device, regulated under 21 CFR 862.3220 and reviewed by the Clinical Toxicology panel.
What device class is JKT?
Class I, regulation 21 CFR 862.3220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JKT?
Across 2 cleared submissions the average was 50 days from receipt to decision (median 50).
Which companies have the most JKT clearances?
Rna Medical Corp. (1); Shaban Mfg. Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JKT
- Run a recall and safety report across every JKT manufacturer
- Watch product code JKT 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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