Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection System

• • Terminated Z-1158-2008 FDA Unclassified (pre-2012) ·initiated 13 Nov 2007

  False negative results due to reagent packs exhibiting low signal.

510(k) Number

K062213 ↗

FDA Product Code

LSE

Device Class

Class I

Regulation

21 CFR Part 866.3235

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K924289 Active Cleared 12 Feb 1993

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  Class II

  FDA 510(k) K930984 Active Cleared 9 Jun 1993

• Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320, 33325 and 33329

  Class II

  FDA 510(k) K963934 Active Cleared 16 Dec 1996

• Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200

  Class II

  FDA 510(k) K041658 Active Cleared 20 Dec 2004

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  Class II

  FDA 510(k) K130053 Active Cleared 19 Sep 2013

• Access Ck-Mb Reagents

  Class II

  FDA 510(k) K945083 Active Cleared 21 Nov 1994

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