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 K261347
Device Name DASH Flu A/B Test
Applicant
Nuclein, LLC
8305 Cross Park Dr.
Austin,  TX  78754
Applicant Contact Ben Treece
Correspondent
Nuclein, LLC
8305 Cross Park Dr.
Austin,  TX  78754
Correspondent Contact Chelynne Lee
Regulation Number866.3980
Classification Product Code
OCC  
Date Received04/24/2026
Decision Date 10/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-