Albumin Bcp

• • Terminated Z-1194-2019 FDA Class II ·initiated 18 Mar 2019

  The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.

510(k) Number

K844426 ↗

FDA Product Code

CJW

Device Class

Class II

Regulation

21 CFR Part 862.1035

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

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• Precimat Glycerol

  Class I

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• Stattek Bun

  Class II

  FDA 510(k) K792328 Active Cleared 18 Dec 1979

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  Class II

  FDA 510(k) K931258 Active Cleared 10 Feb 1994

See all devices from Boehringer Mannheim Corp. →