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 assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
510(k) Number K221007
Device Name cobas HCV
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Applicant Contact Ashley Malich
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588 -2722
Correspondent Contact Ashley Malich
Regulation Number866.3170
Classification Product Code
MZP  
Date Received04/05/2022
Decision Date 11/04/2022
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
-
-