FDA 510(k) Applications for Medical Device:
Calprotectin, Fecal

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K181012 BUHLMANN Laboratories AG Baselstrasse 55
Schonenbuch CH-4124
K182698 DiaSorin Inc. 1951 Northwestern Ave.
Stillwater MN 55082-0285
K130945 EUROSPITAL S.P.A. 3331 EAGLE WATCH DRIVE
WOODSTOCK GA 30189
K160447 EUROSPITAL S.P.A. VIA FLAVIA 122
TRIESTE 34147
K050007 GENOVA DIAGNOSTICS 63 ZILLICOA ST.
ASHEVILLE NC 28801 1074
DEN060001 GENOVA DIAGNOSTICS 63 ZILLICOA ST.
ASHEVILLE NC 28801-1074
K180971 Inova Diagnostics, Inc. 9900 Old Grove Road
San Diego CA 92131-1638
K170993 Inova Diagnostics, Inc. 9900 Old Grove Road
San Diego CA 92131-1638




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