510(k) K231020
- Device
- Alinity c Tricyclic Antidepressants Reagent Kit
- Applicant
- Microgenics Corporation
- 510(k) number
- K231020
- Product code
- LFH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-17
- Date received
- 2023-04-10
- Regulation
- 862.3910
- Classification name
- U.V. Spectrometry, Tricyclic Antidepressant Drugs
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Pranjali Shinde
- Address
- 45600 Kato Rd. Fremont CA US 94538 94538
FDA Registration Numbers#
- 3010939897
- 2246703
- 2030633
- 3005333358
- 2517506
Source Documents#
Other 510(k) Records For Product Code LFH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213875 | DRI TM Tricyclics Serum Tox Assay | Microgenics Corporation | 2022-12-21 |
| K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-18 |
| K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | 1998-08-25 |
| K961393 | TRICYCLICS SERUM TOX ASSAY | Diagnostic Reagents, Inc. | 1996-06-12 |
| K953761 | AXSYM TRICYCLIC ANTIDEPRESSANTS | Abbott Laboratories | 1995-11-22 |