FDA 510(k) Application Details - K952595

Device Classification Name Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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510(K) Number K952595
Device Name Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant CLINICAL STANDARDS LABORATORIES, INC.
2011 EAST UNIVERSITY DR.
RANCHO DOMINGUEZ, CA 90220-6445 US
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Contact JASON J DEGOES
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Regulation Number 866.1700

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Classification Product Code JSO
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Date Received 06/06/1995
Decision Date 04/10/1996
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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