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510(k) K123418

GRAM-NEGATIVE QUICKFISH BC by Advandx, Inc. — Product Code JSS

K123418 is an FDA 510(k) premarket notification submitted by Advandx, Inc. for the device "GRAM-NEGATIVE QUICKFISH BC". The FDA issued a decision of Substantially Equivalent on July 21, 2013. The device falls under product code JSS (Kit, Identification, Enterobacteriaceae), 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
July 21, 2013
Date Received
November 6, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Enterobacteriaceae
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Advandx, Inc.

  • K140619 — MECA XPRESSFISH (October 10, 2014)
  • 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)
  • K092393 — EK/P. AERUGINOSA PNA FISH (September 1, 2009)

Other clearances for product code JSS

  • K150031 — hemoFISH Masterpanel (October 1, 2015)
  • K101558 — GNR TRAFFIC LIGHT PNA FISH (December 16, 2010)
  • K092236 — E.COLI/P. AERUGINOSA PNA FISH (December 16, 2009)
  • K092393 — EK/P. AERUGINOSA PNA FISH (September 1, 2009)
  • K082068 — E. COLI PNA FISH (June 25, 2009)
  • K081433 — EK/P. AERUGINOSA PNA FISH (March 26, 2009)
  • K081309 — E.COLI/P. AERUGINOSA PNA FISH (December 19, 2008)
  • K926002 — ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (September 23, 1993)
  • K926018 — CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM (March 11, 1993)
  • K926017 — CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM (March 11, 1993)

FDA data resources