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 nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
510(k) Number K200748
Device Name Visby Medical Sexual Health
Applicant
Visby Medical
3010 N. First Street
San Jose,  CA  95134
Applicant Contact Carolyn Glickman
Correspondent
Visby Medical
3010 North First Street
San Jose,  CA  95134
Correspondent Contact Beth Lingenfelter
Regulation Number866.3393
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   OUY  
Date Received03/23/2020
Decision Date 08/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Clinical Trials NCT04098900
Reviewed by Third Party No
Combination Product No
-
-