Tricyclic Antidepressants
FDA 510(k) K831736 · Utak Laboratories, Inc.
510(k) numberK831736
Submission
- Device name
- Tricyclic Antidepressants
- Applicant
- Utak Laboratories, Inc.
Mchenry, IL, US - Received
- May 31, 1983
- Decision date
- July 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K903061 | Utak Laboratories Toxicology ControlLAS · Traditional | 04/12/1991SE |
| K883147 | Trace Elements Serum Toxicology ControlJJY · Traditional | 10/06/1988SE |
| K862419 | Serum Vancomycin Toxicology ControlLAS · Traditional | 11/13/1986SE |
| K862418 | Benzodiazepines Toxicology ControlLAS · Traditional | 11/13/1986SE |
| K862421 | Serum Clonazepam Toxicology ControlLAS · Traditional | 11/05/1986SE |
| K862420 | Utak-Stabbs Toxicology ControlJJY · Traditional | 08/04/1986SE |
| K831741 | Flurazepam Toxicology ControlDIF · Traditional | 07/26/1983SE |
| K831738 | Caffine Toxicology ControlLAS · Traditional | 07/26/1983SE |
| K831735 | MaprotilineLAS · Traditional | 07/26/1983SE |
| K831734 | Amoxapine 8-HYDRO-XYAMOXAPINEDIF · Traditional | 07/26/1983SE |
Questions and answers
When was Tricyclic Antidepressants cleared by the FDA?
Tricyclic Antidepressants (K831736) received a 510(k) decision of Substantially Equivalent on July 28, 1983, 58 days after the submission was received.
What is the product code of K831736?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.