• 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, radioallergosorbent (rast) immunological
510(k) Number K220162
Device Name Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
Hycor Biomedical
7272 Chapman Avenue
Garden Grove,  CA  92841
Applicant Contact Irene M. Guzman
Hycor Biomedical
7272 Chapman Avenue
Garden Grove,  CA  92841
Correspondent Contact Irene M. Guzman
Regulation Number866.5750
Classification Product Code
Date Received01/20/2022
Decision Date 02/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No