• 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 K191729
Device Name Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588 -2722
Applicant Contact kaitlyn hameister
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
pleasanton,  CA  94588 -2722
Correspondent Contact kaitlyn hameister
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received06/27/2019
Decision Date 07/24/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-