7 TRICYCLIC ANTIDE PRESSANTS
FDA 510(k) clearance K802245 · decided 1980-10-10
Clearance details
- K-number
- K802245
- Device name
- 7 TRICYCLIC ANTIDE PRESSANTS
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-16
- Decision date
- 1980-10-10
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- LFI
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Walker, MI, 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 |
|---|---|---|
| BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC (K941990) | Bio-Rad | 1995-03-20 |
| BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC (K941994) | Bio-Rad | 1995-03-20 |
| BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS (K934340) | Biosite Incorporated | 1994-12-02 |
Recalls involving this device
No recalls on record reference this clearance.