D-10 Hemoglobin A1c Program
FDA 510(k) clearance K161687 · decided 2016-10-14
Clearance details
- K-number
- K161687
- Device name
- D-10 Hemoglobin A1c Program
- Applicant
- Bio-Rad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-17
- Decision date
- 2016-10-14
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- PDJ
- Device class
- 2
- Regulation number
- 862.1373
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hercules, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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 |