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510(k) K063144

VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM by Ortho-Clinical Diagnostics, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2006
Date Received
October 16, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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