Liquid Chromatography, Amphetamine
The Liquid Chromatography system for Amphetamine is a laboratory analytical device that uses liquid chromatographic techniques to detect and quantify amphetamine in patient specimens for clinical toxicology testing. It is a Class 2 device requiring a 510(k) premarket notification before marketing. The product code is DNI, regulated under 21 CFR 862.3100, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DNI
- Device Class
- FDA class 2
- Regulation Number
- 862.3100
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K941596 | REMEDI HS DRUG PROFILING SYSTEM | Mar 27, 1995 | Substantially Equivalent | Bio-Rad |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.