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510(k) K080459

CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS by Chromsystems Instruments & Chemicals GmbH — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2009
Date Received
February 20, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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