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510(k) K082612

GBS PNA FISH by Advandx, Inc. — Product Code OAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2009
Date Received
September 9, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.

Other clearances by Advandx, Inc.

  • K140619 — MECA XPRESSFISH (October 10, 2014)
  • K123418 — GRAM-NEGATIVE QUICKFISH BC (July 21, 2013)
  • K121991 — ENTEROCOCCUS QUICKFISH BC (January 7, 2013)
  • K113371 — STAPHYLOCOCCUS QUICKFISH BC (April 3, 2012)
  • K101558 — GNR TRAFFIC LIGHT PNA FISH (December 16, 2010)
  • K093024 — YEAST TRAFFIC LIGHT PNA FISH (July 15, 2010)
  • K092784 — C. ALBICANS/C. GLABRATA PNA FISH (March 12, 2010)
  • K092655 — C. ALBICANS PNA FISH (January 19, 2010)
  • K092236 — E.COLI/P. AERUGINOSA PNA FISH (December 16, 2009)
  • K092166 — S. AUREUS/CNS PNA FISH, MODEL KT005 (November 23, 2009)

Other clearances for product code OAH

  • K121991 — ENTEROCOCCUS QUICKFISH BC (January 7, 2013)
  • K083074 — AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT (July 24, 2009)
  • K063127 — ENTEROCOCCUS FAECALIS PNA FISH (December 22, 2006)