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510(k) K141775

SOFIA (R) STREP A+ FIA by Quidel Corporation — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2014
Date Received
July 1, 2014
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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