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 Culture Media, Non-Propagating Transport
510(k) Number K250205
Device Name Babio® Virus Transport Kit (Non-inactivating)
Applicant
Jinan Babio Biotechnology Co., Ltd.
303, Bldg. 5 Of Sme Industrialization Base Of Biomedical Par
1777 Dazheng Rd., High-Tech Zone,
Jinan,  CN 250101
Applicant Contact Xiaotong Zhou
Correspondent
Iyou Health
15308 Cavalier Canyon Dr.
Lakeway,  TX  78734
Correspondent Contact Keqin Gregg
Regulation Number866.2390
Classification Product Code
JSM  
Date Received01/24/2025
Decision Date 09/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-