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FDA 510(k) Application Details - K031899
Device Classification Name
More FDA Info for this Device
510(K) Number
K031899
Device Name
QUICKVUE INFLUENZA A+B TEST
Applicant
QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO, CA 92121 US
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Contact
Robin Weiner
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Regulation Number
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Classification Product Code
PSZ
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Date Received
06/04/2003
Decision Date
09/11/2003
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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