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510(k) K031784

ACON STREP A RAPID TEST DEVICE by ACON Laboratories, Inc. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2003
Date Received
June 10, 2003
Clearance Type
Special
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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