D-10 HEMOGLOBIN A1C
FDA 510(k) clearance K031043 · decided 2003-08-27
Clearance details
- K-number
- K031043
- Device name
- D-10 HEMOGLOBIN A1C
- Applicant
- Bio-Rad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-01
- Decision date
- 2003-08-27
- Days to decision
- 148 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 |
|---|---|---|
| D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laborator recall (Z-1299-2014) | Bio-Rad Laboratories, Inc. | 2014-03-27 |
| D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio recall (Z-0965-2014) | Bio-Rad Laboratories, Inc. | 2014-02-10 |
| D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A recall (Z-0017-2012) | Bio-Rad Laboratories, Inc. | 2011-10-07 |
| D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. P recall (Z-0018-2012) | Bio-Rad Laboratories, Inc. | 2011-10-07 |
| D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Pe recall (Z-0019-2012) | Bio-Rad Laboratories, Inc. | 2011-10-07 |
| Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c recall (Z-1969-2011) | Bio-Rad Laboratories, Inc., Hercules, CA | 2011-04-13 |
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 |