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510(k) K091489

CLEARVIEW ADVANCED STREP A , MODEL 737-430 by Binax, Inc. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2009
Date Received
May 20, 2009
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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