Thin Layer Chromatography, Tricyclic Antidepressant Drugs
The Thin Layer Chromatography assay for Tricyclic Antidepressant Drugs is a laboratory toxicology method used to separate, identify, and semi-quantify tricyclic antidepressants (such as amitriptyline, nortriptyline, and imipramine) in biological specimens such as urine, used for clinical toxicology screening and therapeutic drug monitoring. Classified as a Class 2 device under 21 CFR 862.3910 within the Clinical Toxicology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MLK
- Device Class
- FDA class 2
- Regulation Number
- 862.3910
- 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.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022693 | INSTANT-VIEW TCA URINE TEST | Dec 09, 2002 | Substantially Equivalent | Alfa Scientific Designs, Inc. |
| K010734 | BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 | Jul 30, 2001 | Substantially Equivalent | Branan Medical Corp. |
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.