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510(k) K042169

STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER by Stanbio Laboratory — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2005
Date Received
August 11, 2004
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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