DRI TM Tricyclics Serum Tox Assay
FDA 510(k) clearance K213875 · decided 2022-12-21
Clearance details
- K-number
- K213875
- Device name
- DRI TM Tricyclics Serum Tox Assay
- Applicant
- Microgenics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-12-13
- Decision date
- 2022-12-21
- Days to decision
- 373 days
- Clearance type
- Traditional
- Product code
- LFH
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Alinity c Tricyclic Antidepressants Reagent Kit (K231020) | Microgenics Corporation | 2023-11-17 |
| MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (K983268) | Diagnostic Reagents, Inc. | 1998-11-18 |
| ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (K981801) | Princeton BioMeditech Corp. | 1998-08-25 |
| TRICYCLICS SERUM TOX ASSAY (K961393) | Diagnostic Reagents, Inc. | 1996-06-12 |
| AXSYM TRICYCLIC ANTIDEPRESSANTS (K953761) | Abbott Laboratories | 1995-11-22 |
Recalls involving this device
No recalls on record reference this clearance.