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510(k) K063643

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM by Bio-Rad Laboratories Inc., Clinical Systems Divisi — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2006
Date Received
December 7, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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