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510(k) K083188

VARELISA RECOMBI ANA SCREEN, MODEL 12 596 by Phadia US, Inc. — Product Code LJM

K083188 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "VARELISA RECOMBI ANA SCREEN, MODEL 12 596". The FDA issued a decision of Substantially Equivalent on March 13, 2009. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Phadia US, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2009
Date Received
October 29, 2008
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 Phadia US, Inc.

  • K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (February 13, 2015)
  • K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GB (October 27, 2014)
  • K132631 — EIA SMDP IMMUNOASSAY (August 29, 2014)
  • K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (December 23, 2013)
  • K122197 — AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC I (August 28, 2013)
  • K113841 — IMMUNOCAP ALLERGEN COMPONENTS BUNDLE (September 13, 2012)
  • K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (June 22, 2012)
  • DEN120001 — IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, (February 15, 2012)
  • K111919 — IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS (December 22, 2011)
  • K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (September 30, 2011)

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)
  • K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096 (June 28, 2005)
  • K050625 — VARELISA RECOMBI ANA PROFILE, MODEL 18496 (April 26, 2005)
  • K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (October 26, 2004)
  • K040953 — AESKULISA ANA HEP-2 (June 23, 2004)

FDA data resources