Home / 510(k) Clearances / K062461

510(k) K062461

C. ALBICANS PNA FISH by Advandx, Inc. — Product Code JXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2006
Date Received
August 23, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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 JXB

  • K080719 — YEAST TRAFFIC LIGHT PNA FISH (September 12, 2008)
  • K993554 — YEASTEST (February 10, 2000)
  • K943621 — RAPID YEAST PLUS SYSTEM (January 27, 1995)
  • K935124 — BACTICARD CANDIDA (February 25, 1994)
  • K900112 — MICRORING YT (July 31, 1990)
  • K881925 — VITEK YEAST BIOCHEMICAL CARD (June 16, 1988)
  • K860575 — YEAST IDENTIFICATION PANEL (May 13, 1986)
  • K830286 — YEAST IDENT (April 5, 1983)
  • K802309 — MS-2 IDENTIFICATION SYSTEM (December 1, 1980)
  • K800803 — NITRATE SWAB-RAPID TEST (July 8, 1980)