DRI TM Tricyclics Serum Tox Assay
FDA 510(k) K213875 · Microgenics Corporation
510(k) numberK213875
Submission
- Device name
- DRI TM Tricyclics Serum Tox Assay
- Applicant
- Microgenics Corporation
Fremont, CA, US - Received
- December 13, 2021
- Decision date
- December 21, 2022
- 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
Other 510(k)s with product code LFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231020 | Alinity c Tricyclic Antidepressants Reagent KitLFH · Traditional | Microgenics Corporation | 11/17/2023SE |
| 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 |
| K953761 | Axsym Tricyclic AntidepressantsLFH · Traditional | Abbott Laboratories | 11/22/1995SE |
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| K231020 | Alinity c Tricyclic Antidepressants Reagent KitLFH · Traditional | 11/17/2023SE |
| K231007 | CEDIA Heroin Metabolite (6-AM) AssayDJG · Traditional | 09/27/2023SE |
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| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | 12/09/2019SE |
| K181499 | DRI Cocaine Metabolite AssayDIO · Traditional | 07/06/2018SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | 02/21/2018SE |
| K173195 | DRI Hydrocodone AssayDJG · Traditional | 02/13/2018SE |
Questions and answers
When was DRI TM Tricyclics Serum Tox Assay cleared by the FDA?
DRI TM Tricyclics Serum Tox Assay (K213875) received a 510(k) decision of Substantially Equivalent on December 21, 2022, 373 days after the submission was received.
What is the product code of K213875?
The FDA product code is LFH – U.V. Spectrometry, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.