Triglycerides Gpo Without Free Glycerol

• • Terminated Z-1125-2019 FDA Class II ·initiated 14 Dec 2018 ·on shared 510(k) K873049

  COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over

• • Terminated Z-1930-2015 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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K873049 ↗

FDA Product Code

CDT

Device Class

Class I

Regulation

21 CFR Part 862.1705

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. →