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510(k) K102607

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS by Biomedical Diagnostics (Bmd) SA — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2010
Date Received
September 10, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Biomedical Diagnostics (Bmd) SA

  • 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)
  • K060380 — FIDIS DSDNA (May 2, 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)

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