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 K181443
Device Name Accula RSV Test
Applicant
Mesa Biotech, Inc.
6190 Cornerstone Ct.
Suite 220
San Diego,  CA  92121
Applicant Contact Barbara Stevens
Correspondent
Mesa Biotech, Inc.
6190 Cornerstone Ct.
Suite 220
San Diego,  CA  92121
Correspondent Contact Barbara Stevens
Regulation Number866.3980
Classification Product Code
OCC  
Date Received05/31/2018
Decision Date 11/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-