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 K241580
Device Name Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
Applicant
Abbott Molecular
1300 E Touhy Ave
Des Plaines,  IL  60018
Applicant Contact Stacy Ferguson
Correspondent
Abbott Molecular
1300 E Touhy Ave
Des Plaines,  IL  60018
Correspondent Contact Stacy Ferguson
Regulation Number866.3981
Classification Product Code
QQX  
Subsequent Product Codes
JSM   LIO  
Date Received06/03/2024
Decision Date 12/06/2024
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
Predetermined Change
Control Plan Authorized		 No
-
-