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510(k) K070889

AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 by Wallac OY — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2008
Date Received
March 30, 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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