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FDA 510(k) Application Details - K965190
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
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510(K) Number
K965190
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
ACCUMED INTL., INC.
29299 CLEMENS RD.
SUITE 1K
WESTLAKE, OH 44145 US
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Contact
CYNTHIA C KNAPP
Other 510(k) Applications for this Contact
Regulation Number
866.1640
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Classification Product Code
JWY
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More FDA Info for this Product Code
Date Received
12/24/1996
Decision Date
03/19/1997
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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