MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
FDA 510(k) clearance K063643 · decided 2006-12-27
Clearance details
- K-number
- K063643
- Device name
- MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
- Applicant
- Bio-Rad Laboratories Inc., Clinical Systems Divisi
- Decision
- Substantially Equivalent
- Date received
- 2006-12-07
- Decision date
- 2006-12-27
- Days to decision
- 20 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 |
|---|---|---|
| Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufa recall (Z-1395-2009) | Bio-Rad Laboratories Inc | 2009-05-19 |