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510(k) K050625

VARELISA RECOMBI ANA PROFILE, MODEL 18496 by Sweden Diagnostics (Germany) GmbH — Product Code LJM

K050625 is an FDA 510(k) premarket notification submitted by Sweden Diagnostics (Germany) GmbH for the device "VARELISA RECOMBI ANA PROFILE, MODEL 18496". The FDA issued a decision of Substantially Equivalent on April 26, 2005. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Sweden Diagnostics (Germany) GmbH has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2005
Date Received
March 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Sweden Diagnostics (Germany) GmbH

  • K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096 (June 28, 2005)
  • K042629 — VARELISA SM ANTIBODIES, MODEL 18296 (December 8, 2004)
  • K041173 — CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 (August 2, 2004)
  • K041357 — VARELISA GLIADIN IGG ANTIBODIES (August 2, 2004)
  • K041174 — CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 (July 19, 2004)
  • K041354 — VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 (July 16, 2004)
  • K041040 — VARELISA MPO ANCA, MODEL 17648/17696 (June 16, 2004)

Other clearances for product code LJM

  • K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (November 27, 2018)
  • K151559 — ImmuLisa Enhanced Centromere Antibody ELISA (March 11, 2016)
  • K140493 — ELIA SCL-70S IMMUNOASSAY (October 30, 2014)
  • K123880 — QUANTA FLASH CENTROMERE (February 7, 2014)
  • K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (January 28, 2014)
  • K131185 — ANA SCREEN ELISA (IGG) (July 15, 2013)
  • K083188 — VARELISA RECOMBI ANA SCREEN, MODEL 12 596 (March 13, 2009)
  • K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096 (June 28, 2005)
  • K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (October 26, 2004)
  • K040953 — AESKULISA ANA HEP-2 (June 23, 2004)

FDA data resources