Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K162438
Device Name Sofia Influenza A+B FIA on Sofia 2
Applicant
Quidel Corporation
12544 High Bluff Drive, Suite 200
San Diego,  CA  92130
Applicant Contact Jennifer S. Rial
Correspondent
Quidel Corporation
12544 High Bluff Drive, Suite 200
San Diego,  CA  92130
Correspondent Contact Jennifer S. Rial
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received08/31/2016
Decision Date 04/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-