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510(k) K051200

HEMOGLOBIN A1C REAGENT SET by Teco Diagnostics — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2005
Date Received
May 10, 2005
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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