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510(k) K071132

G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 by Tosoh Bioscience, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2008
Date Received
April 23, 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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