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 Microbial Nucleic Acid Storage And Stabilization Device
510(k) Number K210440
Device Name Disposable Sampler Inactivated Transport Media, Nest ITM
Applicant
Wuxi Nest Biotechnology Co., Ltd.
No. 530 Xida Road, New District
Wuxi,  CN 214012
Applicant Contact Cheng Zhiwei
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road 1
Suite 300
Austin,  TX  78746
Correspondent Contact Giselle Zhang
Classification Product Code
QBD  
Date Received02/12/2021
Decision Date 09/20/2021
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
-
-