U.V. Spectrometry, Tricyclic Antidepressant Drugs
UV spectrometry for tricyclic antidepressant drugs is a laboratory analytical method that uses ultraviolet spectrophotometry to detect and quantify tricyclic antidepressant compounds in biological specimens for therapeutic drug monitoring or toxicological analysis. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LFH and is regulated under 21 CFR 862.3910 within the Clinical Toxicology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LFH
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | Nov 17, 2023 | Substantially Equivalent | Microgenics Corporation |
| K213875 | DRI TM Tricyclics Serum Tox Assay | Dec 21, 2022 | Substantially Equivalent | Microgenics Corporation |
| K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | Nov 18, 1998 | Substantially Equivalent | Diagnostic Reagents, Inc. |
| K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Aug 25, 1998 | Substantially Equivalent | Princeton BioMeditech Corp. |
| K961393 | TRICYCLICS SERUM TOX ASSAY | Jun 12, 1996 | Substantially Equivalent | Diagnostic Reagents, Inc. |
| K953761 | AXSYM TRICYCLIC ANTIDEPRESSANTS | Nov 22, 1995 | Substantially Equivalent | Abbott Laboratories |
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.