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510(k) K171976

Sofia Strep A+ FIA, Sofia 2 Analyzer by Quidel Corporation — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2017
Date Received
June 30, 2017
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

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