Variant II Hemoglobin A1C Program with Models 270-2101NU

• • Terminated Z-1013-2010 FDA Unclassified (pre-2012) ·initiated 15 Jun 2009

  Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.

510(k) Number

K070452 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Kallestad Rsv Microplate Eia

  Class I

  FDA 510(k) K924289 Active Cleared 12 Feb 1993

• Access(R) Total Ige Assay

  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

• Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and Bi

  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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