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 Antibodies, Gliadin
510(k) Number K163177
Device Name ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
Applicant
Immco Diagnostics, Inc.
9870 Hollingson Rd.
Clarence,  NY  14031
Applicant Contact KEVIN LAWSON
Correspondent
Immco Diagnostics, Inc.
9870 Hollingson Rd.
Clarence,  NY  14031
Correspondent Contact KEVIN LAWSON
Regulation Number866.5750
Classification Product Code
MST  
Date Received11/14/2016
Decision Date 07/28/2017
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
Predetermined Change
Control Plan Authorized		 No
-
-