FDA 510(k) Applications Submitted by Michael A. Locke

FDA 510(k) Number Submission Date Device Name Applicant
K140224 01/29/2014 EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) EUROIMMUN US
DEN140002 03/28/2014 EUROIMMUN ANTI-PLA2R IFA EUROIMMUN US
K131185 04/26/2013 ANA SCREEN ELISA (IGG) EUROIMMUN US
K161513 06/02/2016 Anti-Borrelia burgdorferi US Westernblot (IgG) EUROIMMUN US
K131791 06/18/2013 IFA 40: HEP-20-10 EUROIMMUN US
K132195 07/15/2013 EUROIMMUN ANTI-PLA2R ELISA (IGG) EUROIMMUN US INC
K142038 07/28/2014 EUROIMMUN LYME ELISA(IgG/IgM) EUROIMMUN US
K153303 11/16/2015 EUROIMMUN Anti-West Nile Virus ELISA (IgG) EUROIMMUN US, INC.
K153308 11/17/2015 EUROIMMUN Anti-West Nile Virus ELISA (IgM) EUROIMMUN US, INC.
K141827 07/07/2014 EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE EUROIMMUN U.S., Inc.
K172582 08/28/2017 EUROIMMUN IFA Granulocyte MosaicÖ EUROPattern and EUROIMMUN EUROPLUS Granulocyte MosaicÖ EUROPattern Euroimmun US, Inc.
K172722 09/11/2017 Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) EUROIMMUN US, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact