VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU— 510(k) K070452
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K070452 for VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU, Substantially Equivalent on 2007-05-07. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hercules, CA, US
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