Sweden Diagnostics (Germany) GmbH

FDA Regulatory Profile

Sweden Diagnostics (Germany) GmbH appears in FDA public data with 0 recalls, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 28, 2005.

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096June 28, 2005
K050625VARELISA RECOMBI ANA PROFILE, MODEL 18496April 26, 2005
K042629VARELISA SM ANTIBODIES, MODEL 18296December 8, 2004
K041173CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996August 2, 2004
K041357VARELISA GLIADIN IGG ANTIBODIESAugust 2, 2004
K041174CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196July 19, 2004
K041354VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896July 16, 2004
K041040VARELISA MPO ANCA, MODEL 17648/17696June 16, 2004