ClearanceBrief
Company ยท DE

Sweden Diagnostics (Germany) GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2005. Name variants (Inc, Corp, punctuation) are merged.

8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls2
MSTAntibodies, Gliadin2
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)2
LKPAnti-Sm Antibody, Antigen And Control1
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 28, 2005K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096
Sweden Diagnostics (Germany) GmbH, DE
LJM
Apr 26, 2005K050625VARELISA RECOMBI ANA PROFILE, MODEL 18496
Sweden Diagnostics (Germany) GmbH, DE
LJM
Dec 8, 2004K042629VARELISA SM ANTIBODIES, MODEL 18296
Sweden Diagnostics (Germany) GmbH, DE
LKP
Aug 2, 2004K041357VARELISA GLIADIN IGG ANTIBODIES
Sweden Diagnostics (Germany) GmbH, DE
MST
Aug 2, 2004K041173CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
Sweden Diagnostics (Germany) GmbH, DE
MVM
Jul 19, 2004K041174CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196
Sweden Diagnostics (Germany) GmbH, DE
MVM
Jul 16, 2004K041354VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896
Sweden Diagnostics (Germany) GmbH, DE
MST
Jun 16, 2004K041040VARELISA MPO ANCA, MODEL 17648/17696
Sweden Diagnostics (Germany) GmbH, DE
MOB

Latest recalls

DateFirm and productCodeLinked 510(k)
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