Thin Layer Chromatography, Amphetamine
The Thin Layer Chromatography Amphetamine test is a laboratory assay that uses thin layer chromatographic separation to detect and identify amphetamine compounds in urine or other biological specimens, used in drug screening and toxicology investigations. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3100 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- DIT
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972577 | QUICK SCREEN ONE STEP AMPHETAMINE TEST | Aug 20, 1997 | Substantially Equivalent | PHAMATECH |
| K910525 | MICROLINE SCREEN FOR METHAMPHETAMINE | Apr 05, 1991 | Substantially Equivalent | DRUG SCREENING SYSTEMS, INC. |
| K901276 | HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL | Apr 26, 1990 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K790805 | DRUG ABUSE DIPSTICKS | Jun 06, 1979 | Substantially Equivalent | TECHNICAL RESOURCES, INC. |
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.