VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
FDA 510(k) clearance K063400 · decided 2006-12-01
Clearance details
- K-number
- K063400
- Device name
- VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
- Applicant
- Bio-Rad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-09
- Decision date
- 2006-12-01
- Days to decision
- 22 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A recall (Z-1898-2011) | Bio-Rad Laboratories Inc | 2011-04-06 |
| Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog N recall (Z-1342-2011) | Bio-Rad Laboratories Inc | 2011-02-17 |
| Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad La recall (Z-0867-2010) | Bio-Rad Laboratories Inc | 2010-02-26 |
| Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, recall (Z-1041-2009) | Bio-Rad Laboratories Inc | 2009-03-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MONOLISA ANTI-HBC IGM EIA (P060034/S008) | Bio-Rad Laboratories, Inc. | 2014-03-19 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005) | Bio-Rad Laboratories, Inc. | 2011-04-28 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003) | Bio-Rad Laboratories, Inc. | 2010-12-30 |
| MONOLISA ANTI-HBC IGM EIA (P060034/S005) | Bio-Rad Laboratories, Inc. | 2010-11-23 |