FDA 510(k) Application Details - K962150

Device Classification Name Panels, Test, Susceptibility, Antimicrobial

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510(K) Number K962150
Device Name Panels, Test, Susceptibility, Antimicrobial
Applicant DADE INTL., INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,, CA 95691 US
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Contact SHARON CULLEN
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Regulation Number 866.1640

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Classification Product Code LTT
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Date Received 06/04/1996
Decision Date 08/16/1996
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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