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FDA 510(k) Application Details - K964496
Device Classification Name
Susceptibility Test Discs, Antimicrobial
More FDA Info for this Device
510(K) Number
K964496
Device Name
Susceptibility Test Discs, Antimicrobial
Applicant
UNIPATH LTD.
15 OAK ST.
BEVERLY FARMS, MA 01915 US
Other 510(k) Applications for this Company
Contact
FRAN WHITE
Other 510(k) Applications for this Contact
Regulation Number
866.1620
More FDA Info for this Regulation Number
Classification Product Code
JTN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/08/1996
Decision Date
02/06/1997
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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