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510(k) K010582

ACON STREP A RAPID TEST STRIP by Acon Laboratories Co. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2001
Date Received
February 27, 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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