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FDA 510(k) Application Details - K991726
Device Classification Name
Antisera, All Groups, Streptococcus Spp.
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510(K) Number
K991726
Device Name
Antisera, All Groups, Streptococcus Spp.
Applicant
BINAX, INC.
217 READ ST.
PORTLAND, ME 04103 US
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Contact
PAMELA S ANGELL
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Regulation Number
866.3740
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Classification Product Code
GTZ
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More FDA Info for this Product Code
Date Received
05/20/1999
Decision Date
08/27/1999
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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