TD Tricyclic Antidepressants
FDA 510(k) K853113 · Abbott Laboratories
510(k) numberK853113
Submission
- Device name
- TD Tricyclic Antidepressants
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- July 24, 1985
- Decision date
- August 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Specialty
- Clinical Toxicology
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
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Questions and answers
When was TD Tricyclic Antidepressants cleared by the FDA?
TD Tricyclic Antidepressants (K853113) received a 510(k) decision of Substantially Equivalent on August 12, 1985, 19 days after the submission was received.
What is the product code of K853113?
The FDA product code is LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.