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FDA 510(k) Application Details - K102922
Device Classification Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
More FDA Info for this Device
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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More FDA Info for this Product Code
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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