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510(k) K060380

FIDIS DSDNA by Biomedical Diagnostics (Bmd) SA — Product Code LSW

K060380 is an FDA 510(k) premarket notification submitted by Biomedical Diagnostics (Bmd) SA for the device "FIDIS DSDNA". The FDA issued a decision of Substantially Equivalent on May 2, 2006. The device falls under product code LSW (Anti-Dna Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Biomedical Diagnostics (Bmd) SA has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2006
Date Received
February 14, 2006
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 Biomedical Diagnostics (Bmd) SA

  • K102607 — FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS (December 3, 2010)
  • K100917 — FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM (November 3, 2010)
  • K070458 — MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 (December 21, 2007)
  • K071210 — MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 (December 19, 2007)
  • K061794 — FIDIS TM THYRO, MODEL MX002 (November 21, 2006)
  • K053383 — FIDIS CELIAC (March 29, 2006)
  • K053653 — FIDIS CONNECTIVE 10, MODEL MX006 (March 13, 2006)
  • K053012 — FIDIS VASCULITIS, MODEL MX007 (March 2, 2006)
  • K050286 — FIDIS CONNECTIVE 8 (October 3, 2005)

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)
  • 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