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 system, test, human chorionic gonadotropin
510(k) Number K223690
Device Name iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
Applicant
Shenzhen YHLO Biotech Co., LTD.
Building 1, YHLO Biopark, Baolong 2nd Road
Baolong Subdistrict, Longgang District
Shenzhen,  CN 518116
Applicant Contact Ying Dai
Correspondent
Shenzhen YHLO Biotech Co., LTD.
Building 1, YHLO Biopark, Baolong 2nd Road
Baolong Subdistrict, Longgang District
Shenzhen,  CN 518116
Correspondent Contact Chungen QIAN
Regulation Number862.1155
Classification Product Code
DHA  
Subsequent Product Code
JJE  
Date Received12/09/2022
Decision Date 12/11/2023
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
-
-