FDA 510(k) Application Details - K000687

Device Classification Name Antigens, Nontreponemal, All

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510(K) Number K000687
Device Name Antigens, Nontreponemal, All
Applicant BEACON BIOLOGICALS, INC.
6004 GLENDALE DR.
BOCA RATON, FL 33433 US
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Contact KANTI DAYA
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Regulation Number 866.3820

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Classification Product Code GMQ
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Date Received 02/29/2000
Decision Date 06/12/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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