Thin Layer Chromatography, Barbiturate
The Thin Layer Chromatography system for Barbiturate is a laboratory analytical device used to separate and identify barbiturate compounds in biological samples for clinical toxicology testing. It is a Class 2 device, carrying moderate risk and requiring a 510(k) premarket notification before it can be marketed. The product code is DKX, regulated under 21 CFR 862.3150, within the Clinical Toxicology specialty. This product is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DKX
- Device Class
- FDA class 2
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
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 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.