Gas Chromatograph, Carbon-Monoxide
This device is a gas chromatograph used in clinical toxicology to measure carbon monoxide in blood specimens, providing a quantitative analytical method for confirming and assessing the severity of carbon monoxide poisoning. It is classified as FDA Class 1, subject only to general controls with no premarket notification required. The product code is JKT, regulated under 21 CFR 862.3220, and assigned to the Clinical Toxicology medical specialty.
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Basic Information
- Product Code
- JKT
- Device Class
- FDA class 1
- Regulation Number
- 862.3220
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.