The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue Influenza A+b Test.
Device ID | K031899 |
510k Number | K031899 |
Device Name: | QUICKVUE INFLUENZA A+B TEST |
Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
Contact | Robin Weiner |
Correspondent | Robin Weiner QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
Product Code | PSZ |
CFR Regulation Number | 866.3328 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-04 |
Decision Date | 2003-09-11 |
Summary: | summary |