Boehringer Mannheim/Hitachi 747 Chemistry Analyzer

• • Terminated Z-1428-04 FDA Unclassified (pre-2012) ·initiated 6 Aug 2004

  A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.

• • Terminated Z-1432-04 FDA Unclassified (pre-2012) ·initiated 6 Aug 2004

  A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.

510(k) Number

K901003 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Unimeter 330K

  Class II

  FDA 510(k) K822441 Active Cleared 8 Oct 1982

• 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

• Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent, Catalog Number 1877844

  Class II

  FDA 510(k) K981883 Active Cleared 7 Jul 1998

• 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. →