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 Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K171974
Device Name Solana RSV+hMPV Assay
Applicant
Quidel Corporation
2005 E. State St., Suite# 100
Athens,  OH  45701
Applicant Contact Ronald H. Lollar
Correspondent
Quidel Corporation
2005 E. State St., Suite# 100
Athens,  OH  45701
Correspondent Contact Ronald H. Lollar
Regulation Number866.3980
Classification Product Code
OCC  
Date Received06/30/2017
Decision Date 10/16/2017
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
Predetermined Change
Control Plan Authorized		 No
-
-