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510(k) K090939

ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 by Roche Diagnostics — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2009
Date Received
April 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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