MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
FDA 510(k) clearance K983268 · decided 1998-11-18
Clearance details
- K-number
- K983268
- Device name
- MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
- Applicant
- Diagnostic Reagents, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-17
- Decision date
- 1998-11-18
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- LFH
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Sunnyvale, 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 |
| DRI TM Tricyclics Serum Tox Assay (K213875) | Microgenics Corporation | 2022-12-21 |
| 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.