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510(k) K982373

UNI-GOLD STREP A TEST KIT by Trinity Biotech, Plc — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1999
Date Received
July 7, 1998
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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