Boehringer Mannheim/ Hitachi 911 Analyzer

• • Terminated Z-1929-2015 FDA Class II ·initiated 7 May 2015

  Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

510(k) Number

K921661 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Precinorm Hdl Cholesterol Control Material for Ref

  Class I

  FDA 510(k) K902569 Active Cleared 9 Aug 1990

• Precimat Glycerol

  Class I

  FDA 510(k) K780439 Active Cleared 18 Apr 1978

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  Class II

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• Stattek Bun

  Class II

  FDA 510(k) K792328 Active Cleared 18 Dec 1979

• Softtouch II Lancet Device

  Class II

  FDA 510(k) K931258 Active Cleared 10 Feb 1994

See all devices from Boehringer Mannheim Corp. →