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510(k) K120889

AESKUSLIDES ANA HEP-2 by Aesku Diagnostics — Product Code DHN

K120889 is an FDA 510(k) premarket notification submitted by Aesku Diagnostics for the device "AESKUSLIDES ANA HEP-2". The FDA issued a decision of Substantially Equivalent on October 15, 2012. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, 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
October 15, 2012
Date Received
March 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, 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)
  • 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)
  • K081104 — AESKULISA ANA HEP-2, REF 30-7115US (May 2, 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 DHN

  • K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine (April 29, 2022)
  • K172745 — ImmuGlo HEp-2 Elite IFA (June 5, 2018)
  • K153117 — AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (July 28, 2016)
  • K160265 — Image Navigator by Immuno Concepts (June 17, 2016)
  • K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (April 17, 2015)
  • K150155 — NOVA Lite DAPI ANA Kit (April 8, 2015)
  • K131791 — IFA 40: HEP-20-10 (February 26, 2014)
  • K070763 — EUROIMMUN ANA IFA: HEP-20-10 (May 22, 2007)
  • K042680 — RHIGENE HEP-ANA TEST SYSTEM (November 19, 2004)
  • K024220 — LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 (January 17, 2003)

FDA data resources