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 Calprotectin, Fecal
510(k) Number K181012
Device Name BUHLMANN fCAL ELISA
Applicant
Buhlmann Laboratories AG
Baselstrasse 55
Schonenbuch,  CH CH-4124
Applicant Contact Alicja Ritz
Correspondent
Mapi Srs, an Icon Plc Company
2343 Alexandria Dr., Suite 100
Lexington,  KY  40504
Correspondent Contact Roshana Ahmed
Regulation Number866.5180
Classification Product Code
NXO  
Date Received04/17/2018
Decision Date 06/04/2018
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
-
-