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510(k) K130775

DUET SYSTEM by Bioview , Ltd. — Product Code NTH

K130775 is an FDA 510(k) premarket notification submitted by Bioview , Ltd. for the device "DUET SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 2014. The device falls under product code NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays), a Class II device regulated under 21 CFR 866.4700. Bioview , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2014
Date Received
March 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Device Class
Class II
Regulation Number
866.4700
Review Panel
PA
Submission Type

Other clearances by Bioview , Ltd.

  • K061602 — DUET SYSTEM (January 23, 2007)
  • K050840 — MODIFICATION TO DUET SYSTEM (August 16, 2005)
  • K040591 — DUET SYSTEM (September 16, 2004)
  • K030192 — DUET SYSTEM (August 20, 2003)

Other clearances for product code NTH

  • K122554 — GENASIS SCANVIEW SYSTEM (February 7, 2013)
  • K110345 — SCANVIEW SYSTEM (October 19, 2011)
  • K101291 — SCANVIEW HER2/NEU FISH SYSTEM (November 23, 2010)
  • K080909 — ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (October 17, 2008)
  • K043519 — ARIOL HER-2/NEU FISH (April 25, 2005)
  • K042542 — CYTOVISION FOR CEP XY (January 10, 2005)
  • DEN040010 — VYSIS AUTOVYSION SYSTEM (December 13, 2004)

FDA data resources