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 Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K241652
Device Name DASH® SARS-CoV-2 & 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 Number866.3981
Classification Product Code
QOF  
Subsequent Product Code
NSU  
Date Received06/07/2024
Decision Date 12/20/2024
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
Recalls CDRH Recalls
-
-