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FDA 510(k) Application Details - K001721
Device Classification Name
Panels, Test, Susceptibility, Antimicrobial
More FDA Info for this Device
510(K) Number
K001721
Device Name
Panels, Test, Susceptibility, Antimicrobial
Applicant
PASCO LABORATORIES, INC.
12750 WEST 42ND AVE.
WHEAT RIDGE, CO 80033 US
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Contact
LINDA K DILLON
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
LTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/06/2000
Decision Date
08/04/2000
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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