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 Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
510(k) Number K233358
Device Name SCoV-2 Ag Detect Rapid Test
Applicant
InBios International, Inc.
307 Westlake Ave N, Suite 300
Seattle,  WA  98109
Applicant Contact Annabel Tsai
Correspondent
InBios International, Inc.
307 Westlake Ave N, Suite 300
Seattle,  WA  98109
Correspondent Contact Estela Raychaudhuri
Classification Product Code
QVF  
Date Received09/29/2023
Decision Date 08/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Dual Track
Reviewed by Third Party No
Combination Product No
-
-