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510(k) K013379

SAS STREPALERT by Sa Scientific, Inc. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2001
Date Received
October 12, 2001
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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