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510(k) K081104

AESKULISA ANA HEP-2, REF 30-7115US by Aesku Diagnostics — Product Code LKJ

K081104 is an FDA 510(k) premarket notification submitted by Aesku Diagnostics for the device "AESKULISA ANA HEP-2, REF 30-7115US". The FDA issued a decision of Substantially Equivalent on May 2, 2008. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Aesku Diagnostics has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2008
Date Received
April 18, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Antinuclear Antibody, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Aesku Diagnostics

  • K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK (December 5, 2013)
  • K120889 — AESKUSLIDES ANA HEP-2 (October 15, 2012)
  • K091859 — AESKU PR3 (June 3, 2010)
  • K091860 — AESKULISA MPO, MODEL 30-7303US (February 23, 2010)
  • K081251 — MODIFICATION TO AESKULISA DS DNA G (May 13, 2008)
  • K052439 — AESKULISA GLIA A AND AESKULISA GLIA G (February 7, 2006)
  • K041628 — AESKULISA DS DNA G (October 14, 2004)
  • K041753 — AESKULISA ENA 6 S (July 14, 2004)

Other clearances for product code LKJ

  • K210902 — EliA Ro52, EliA Ro60 (July 27, 2022)
  • K113610 — ANA-SCREEN WITH MDSS (July 9, 2012)
  • K082759 — ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMU (April 10, 2009)
  • K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL (December 20, 2004)
  • K042416 — ATHENA MULTI-LYTE ANA-II TEST SYSTEM (October 8, 2004)
  • K034013 — REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (January 8, 2004)
  • K030775 — AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM (May 12, 2003)
  • K024218 — LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (January 17, 2003)
  • K024232 — LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (January 17, 2003)
  • K024223 — LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 (January 13, 2003)

FDA data resources