MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM— 510(k) K063643
Substantially EquivalentBio-Rad Laboratories Inc., Clinical Systems Divisi
FDA 510(k) clearance K063643 for MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM, Substantially Equivalent on 2006-12-27. Applicant: Bio-Rad Laboratories Inc., Clinical Systems Divisi.
Clearance details
- Applicant
- Bio-Rad Laboratories Inc., Clinical Systems Divisi
- 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.