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510(k) K133343

WONDFO RAPID STREP A TEST by Guangzhou Wondfo Biotech Co., Ltd. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2014
Date Received
October 30, 2013
Clearance Type
Traditional
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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