FDA 510(k) Application Details - K991633

Device Classification Name

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510(K) Number K991633
Device Name QUICKVUE INFLUENZA A/B TEST
Applicant QUIDEL CORP.
10165 MCKELLAR CT.
SAN DIEGO, CA 92121 US
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Contact MARY DE ARMOND
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Regulation Number

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Classification Product Code PSZ
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Date Received 05/12/1999
Decision Date 09/24/1999
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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