FDA 510(k) Application Details - K962744

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

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510(K) Number K962744
Device Name Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant PREPARED MEDIA LABORATORY, INC.
15845 SW 72ND AVE.
BLDG. C
PORTLAND, OR 97224 US
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Contact GARY WICKLUND
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Regulation Number 866.1700

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Classification Product Code JSO
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Date Received 07/15/1996
Decision Date 10/15/1996
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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