BENZODIAZEPINES BY REMEDI HS
FDA 510(k) clearance K955116 · decided 1996-01-30
Clearance details
- K-number
- K955116
- Device name
- BENZODIAZEPINES BY REMEDI HS
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1995-11-09
- Decision date
- 1996-01-30
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- LAA
- Device class
- 2
- Regulation number
- 862.3170
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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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 |