VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
FDA 510(k) clearance K972609 · decided 1997-08-06
Clearance details
- K-number
- K972609
- Device name
- VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1997-07-11
- Decision date
- 1997-08-06
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- LCQ
- Device class
- 2
- Regulation number
- 862.3450
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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| INNOFLOUR GENTAMICIN (K841865) | Innotron Diagnostics | 1984-05-31 |
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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 |