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FDA 510(k) Applications Submitted by EURO-DIAGNOSTICA AB
FDA 510(k) Number
Submission Date
Device Name
Applicant
K091657
06/09/2009
IMMUNOSCAN CCPLUS
EURO-DIAGNOSTICA AB
K062045
07/19/2006
EDIA ANTI-CCP
EURO-DIAGNOSTICA AB
K971464
04/22/1997
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
EURO-DIAGNOSTICA AB
K971689
05/07/1997
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
EURO-DIAGNOSTICA AB
K971690
05/07/1997
IMMUNOSCAN PR3-ANCA
EURO-DIAGNOSTICA AB
K093908
12/22/2009
CCPOINT
EURO-DIAGNOSTICA AB
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