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510(k) K140619

MECA XPRESSFISH by Advandx, Inc. — Product Code MYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2014
Date Received
March 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Advandx, Inc.

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  • 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 MYI

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  • K090301 — BINAXNOW PBP2A TEST, MODEL 890-000 (April 14, 2010)
  • K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (February 24, 2010)
  • K062864 — MASTALEX -MRSA, MODEL RST501 (October 18, 2006)
  • K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST (April 2, 2002)
  • K011400 — MRSA-SCREEN (March 27, 2002)
  • K010858 — VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (May 24, 2001)
  • K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY (July 9, 1999)