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FDA 510(k) Application Details - K010363
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K010363
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
AB BIODISK
DALVAGEN 10
SOLNA 16956 SE
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Contact
ANNE BOLMSTROM
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
02/07/2001
Decision Date
04/09/2001
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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