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FDA 510(k) Application Details - K993102
Device Classification Name
Panels, Test, Susceptibility, Antimicrobial
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510(K) Number
K993102
Device Name
Panels, Test, Susceptibility, Antimicrobial
Applicant
DADE MICROSCAN, INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO, CA 95691 US
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Contact
TREVOR WALL
Other 510(k) Applications for this Contact
Regulation Number
866.1640
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Classification Product Code
LTT
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More FDA Info for this Product Code
Date Received
09/16/1999
Decision Date
12/02/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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