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 K241806
Device Name Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
Applicant
Life Technologies Corporation
6055 Sunol Blvd.
Pleasanton,,  CA  94566
Applicant Contact Stacey Moltchanoff
Correspondent
Life Technologies Corporation
6055 Sunol Blvd.
Pleasanton,,  CA  94566
Correspondent Contact Stacey Moltchanoff
Regulation Number866.3981
Classification Product Code
QOF  
Date Received06/21/2024
Decision Date 01/08/2025
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
-
-