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510(k) K092603

COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY by Roche Diagnostics — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2009
Date Received
August 25, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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