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510(k) K100200

ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 by Siemens Healthcare Diagnostics — Product Code LDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2010
Date Received
January 25, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Acetaminophen
Device Class
Class II
Regulation Number
862.3030
Review Panel
TX
Submission Type

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