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510(k) K041628

AESKULISA DS DNA G by Aesku Diagnostics — Product Code LSW

K041628 is an FDA 510(k) premarket notification submitted by Aesku Diagnostics for the device "AESKULISA DS DNA G". The FDA issued a decision of Substantially Equivalent on October 14, 2004. The device falls under product code LSW (Anti-Dna Antibody, Antigen And 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 14, 2004
Date Received
June 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Antibody, Antigen And 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)
  • K081104 — AESKULISA ANA HEP-2, REF 30-7115US (May 2, 2008)
  • K052439 — AESKULISA GLIA A AND AESKULISA GLIA G (February 7, 2006)
  • K041753 — AESKULISA ENA 6 S (July 14, 2004)

Other clearances for product code LSW

  • K172348 — AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Dem (February 16, 2018)
  • K152013 — QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Contro (April 11, 2016)
  • K081251 — MODIFICATION TO AESKULISA DS DNA G (May 13, 2008)
  • K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 (December 7, 2007)
  • K060380 — FIDIS DSDNA (May 2, 2006)
  • K921658 — ANTI-DSDNA ANTIBODY TEST (March 22, 1993)
  • K872085 — THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS (September 1, 1987)

FDA data resources