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FDA 510(k) Application Details - K955920
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K955920
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
AB BIODISK
DAVAGEN 10
S-171 36
SOLNA SE
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Contact
ANNE BOLMSTROM
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
JWY
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More FDA Info for this Product Code
Date Received
11/01/1995
Decision Date
02/22/1996
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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