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FDA 510(k) Application Details - K023556
Device Classification Name
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510(K) Number
K023556
Device Name
FLU OIA A/B TEST KIT
Applicant
THERMO BIOSTAR, INC.
331 SOUTH 104 ST.
LOUISVILLE, CO 80027 US
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Contact
JOHN G ADAMS
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Regulation Number
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Classification Product Code
PSZ
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Date Received
10/23/2002
Decision Date
03/27/2003
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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