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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
Other 510(k) Applications for this Contact
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
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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