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. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories Inc., Clinical Systems Divisi
- 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
- Special
- Location
- Hercules, CA, US
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