BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC
FDA 510(k) clearance K941994 · decided 1995-03-20
Clearance details
- K-number
- K941994
- Device name
- BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1994-04-25
- Decision date
- 1995-03-20
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- LFI
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hercules, 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 |
|---|---|---|
| BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC (K941990) | Bio-Rad | 1995-03-20 |
| BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS (K934340) | Biosite Incorporated | 1994-12-02 |
| 7 TRICYCLIC ANTIDE PRESSANTS (K802245) | Technicon Instruments Corp. | 1980-10-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |