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FDA 510(k) Application Details - K962867
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K962867
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
SENSITITRE ALAMAR
29299 CLEMENS RD.
SUITE 1K
WESTLAKE, OH 44145 US
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Contact
REBECCA D FIELDS
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
07/23/1996
Decision Date
09/30/1996
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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