Home / 510(k) Clearances / K070531

510(k) K070531

ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER by Thermo Fisher Scientific — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2007
Date Received
February 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

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