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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.
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