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
Other 510(k) Applications for this Company
Contact Robin Weiner
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code PSZ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact