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510(k) K092166

S. AUREUS/CNS PNA FISH, MODEL KT005 by Advandx, Inc. — Product Code NXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2009
Date Received
July 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Device Class
Class I
Regulation Number
866.3700
Review Panel
MI
Submission Type

The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6).

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)
  • K092393 — EK/P. AERUGINOSA PNA FISH (September 1, 2009)

Other clearances for product code NXX

  • K113371 — STAPHYLOCOCCUS QUICKFISH BC (April 3, 2012)
  • K091827 — S. AUREUS PNA FISH (August 18, 2009)
  • K060099 — S. AUREUS PNA FISH (May 8, 2006)