VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE— 510(k) K130860
Substantially EquivalentBio-Rad Laboratories, Inc., Clinical Systems Divis
FDA 510(k) clearance K130860 for VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE, Substantially Equivalent on 2013-04-25. Applicant: Bio-Rad Laboratories, Inc., Clinical Systems Divis.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc., Clinical Systems Divis
- Product code
- Code LCP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hercules, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.