VARIANT II HEMOGLOBIN A1C PROGRAM
FDA 510(k) clearance K984268 · decided 1998-12-17
Clearance details
- K-number
- K984268
- Device name
- VARIANT II HEMOGLOBIN A1C PROGRAM
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1998-11-30
- Decision date
- 1998-12-17
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270- recall (Z-1901-2010) | Bio-Rad Laboratories Inc | 2010-06-25 |
| VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Numbe recall (Z-1902-2010) | Bio-Rad Laboratories Inc | 2010-06-25 |
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 |