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 radioimmunoassay, free thyroxine
510(k) Number K182423
Device Name MAGLUMI 2000 FT4
Applicant
Shenzhen New Industries Biomedical Engineering Co., Ltd
No.16, Jinhui Road, Pingshan New District
Shenzhen,  CN 518122
Applicant Contact Jie Rao
Correspondent
LSI International Inc
504E Diamond Ave., Suite F
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.1695
Classification Product Code
CEC  
Date Received09/06/2018
Decision Date 10/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-