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510(k) K073370

TC MATRIX CLINICAL CHEMISTRY ANALYZER by Teco Diagnostics — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2008
Date Received
November 30, 2007
Clearance Type
Traditional
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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