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FDA 510(k) Application Details - K080019
Device Classification Name
Susceptibility Test Discs, Antimicrobial
More FDA Info for this Device
510(K) Number
K080019
Device Name
Susceptibility Test Discs, Antimicrobial
Applicant
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA, CA 93455 US
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Contact
WENDY PHILLIPS
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Regulation Number
866.1620
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Classification Product Code
JTN
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More FDA Info for this Product Code
Date Received
01/03/2008
Decision Date
01/29/2008
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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