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 Specimen Nucleic Acid Sars-Cov-2 Test
510(k) Number K233453
Device Name Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
Applicant
Life Technologies Corporation
6055 Sunol Boulevard
Pleasanton,  CA  94566
Applicant Contact Ian McGill
Correspondent
Life Technologies Corporation
6055 Sunol Boulevard
Pleasanton,  CA  94566
Correspondent Contact Ian McGill
Regulation Number866.3981
Classification Product Code
QQX  
Date Received10/20/2023
Decision Date 07/10/2024
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
-
-