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 Assay, Glycosylated Hemoglobin
510(k) Number K192369
Device Name PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
Applicant
Ixensor Co, Ltd.
6f., #9, Aly. 2, Ln. 35, Jihu Rd.. Neihu Dist.
Taipei City,  TW 114
Applicant Contact Evita Chen
Correspondent
Ivdd Regulatory Consultant
29122 Rancho Viejo Rd., Suite 212
San Juan,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number864.7470
Classification Product Code
LCP  
Date Received08/30/2019
Decision Date 10/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-