Ldl Cholesterol (Automated)

• • Terminated Z-0977-2013 FDA Class II ·initiated 28 Nov 2012 ·on shared 510(k) K022519

  An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

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

510(k) Number

K022519 ↗

FDA Product Code

JHM

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Creatine Kinase (Ck-Nac)

  Class II

  FDA 510(k) K013912 Active Cleared 18 Jan 2002

• Chemistry Calibrator

  Class II

  FDA 510(k) K020454 Active Cleared 8 Apr 2002

• Albumin

  Class II

  FDA 510(k) K003327 Active Cleared 5 Dec 2000

• Jas Magnesium Reagent

  Class I

  FDA 510(k) K003835 Active Cleared 23 Mar 2001

• Glucose (Hexokinase)

  Class II

  FDA 510(k) K011900 Active Cleared 31 Jul 2001

• Direct Bilirubin

  Class II

  FDA 510(k) K003693 Active Cleared 29 Jan 2001

See all devices from Jas Diagnostic, Inc. →