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510(k) K040953

AESKULISA ANA HEP-2 by Aesku, Inc. — Product Code LJM

K040953 is an FDA 510(k) premarket notification submitted by Aesku, Inc. for the device "AESKULISA ANA HEP-2". The FDA issued a decision of Substantially Equivalent on June 23, 2004. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Aesku, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2004
Date Received
April 12, 2004
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 Aesku, Inc.

  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)
  • K051492 — AESKULISA ASCA A (November 14, 2005)
  • K042644 — AESKULISA TTG A AND AESKULISA TTG G (June 1, 2005)
  • K040463 — AESKULISA CARDIOLIPIN AGM (May 12, 2004)
  • K032469 — AESKULISA ANA 8PRO (December 16, 2003)

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)
  • K050625 — VARELISA RECOMBI ANA PROFILE, MODEL 18496 (April 26, 2005)
  • K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (October 26, 2004)

FDA data resources