FDA 510(k) Application Details - K102922

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

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510(K) Number K102922
Device Name Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Applicant HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA, CA 93455 US
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Contact RENE CLASEN
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Regulation Number 866.1700

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Classification Product Code JSO
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Date Received 10/01/2010
Decision Date 05/04/2011
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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