Axsym Tricyclic Antidepressants
FDA 510(k) K953761 · Abbott Laboratories
510(k) numberK953761
Submission
- Device name
- Axsym Tricyclic Antidepressants
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 11, 1995
- Decision date
- November 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFH – U.V. Spectrometry, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K231020 | Alinity c Tricyclic Antidepressants Reagent KitLFH · Traditional | Microgenics Corporation | 11/17/2023SE |
| K213875 | DRI TM Tricyclics Serum Tox AssayLFH · Traditional | Microgenics Corporation | 12/21/2022SE |
| K983268 | Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional | Diagnostic Reagents, Inc. | 11/18/1998SE |
| K981801 | Accusign Tca, Biosign Tca, Staus DS TcaLFH · Traditional | Princeton BioMeditech Corp. | 08/25/1998SE |
| K961393 | Tricyclics Serum Tox AssayLFH · Traditional | Diagnostic Reagents, Inc. | 06/12/1996SE |
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Questions and answers
When was Axsym Tricyclic Antidepressants cleared by the FDA?
Axsym Tricyclic Antidepressants (K953761) received a 510(k) decision of Substantially Equivalent on November 22, 1995, 103 days after the submission was received.
What is the product code of K953761?
The FDA product code is LFH – U.V. Spectrometry, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.