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510(k) K081251

MODIFICATION TO AESKULISA DS DNA G by Aesku Diagnostics — Product Code LSW

K081251 is an FDA 510(k) premarket notification submitted by Aesku Diagnostics for the device "MODIFICATION TO AESKULISA DS DNA G". The FDA issued a decision of Substantially Equivalent on May 13, 2008. 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
May 13, 2008
Date Received
May 2, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

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)
  • 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 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)
  • K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 (December 7, 2007)
  • K060380 — FIDIS DSDNA (May 2, 2006)
  • K041628 — AESKULISA DS DNA G (October 14, 2004)
  • K921658 — ANTI-DSDNA ANTIBODY TEST (March 22, 1993)
  • K872085 — THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS (September 1, 1987)

FDA data resources