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FDA 510(k) Application Details - K982373
Device Classification Name
Antigens, All Groups, Streptococcus Spp.
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510(K) Number
K982373
Device Name
Antigens, All Groups, Streptococcus Spp.
Applicant
TRINITY BIOTECH, PLC
575 Shirlynn Court
Los Altos, CA 94022 US
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Contact
Erika B Ammirati
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Regulation Number
866.3740
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Classification Product Code
GTY
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More FDA Info for this Product Code
Date Received
07/07/1998
Decision Date
02/11/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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