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510(k) K092784

C. ALBICANS/C. GLABRATA PNA FISH by Advandx, Inc. — Product Code NZS

K092784 is an FDA 510(k) premarket notification submitted by Advandx, Inc. for the device "C. ALBICANS/C. GLABRATA PNA FISH". The FDA issued a decision of Substantially Equivalent on March 12, 2010. The device falls under product code NZS (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast), a Class I device regulated under 21 CFR 866.2660. Advandx, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2010
Date Received
September 10, 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, Yeast
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.

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

Other clearances for product code NZS

  • K093024 — YEAST TRAFFIC LIGHT PNA FISH (July 15, 2010)
  • K092655 — C. ALBICANS PNA FISH (January 19, 2010)

FDA data resources