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510(k) K070819

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, by Bio-Rad Laboratories Inc., Clinical Systems Divisi — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2007
Date Received
March 26, 2007
Clearance Type
Traditional
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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