D-100 HbA1c, D-100 HbA1c Calibrator Pack— 510(k) K151321
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K151321 for D-100 HbA1c, D-100 HbA1c Calibrator Pack, Substantially Equivalent on 2015-12-09. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code PDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1373
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hercules, CA, US
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