Enzymatic Creatinine Assay (265 Series)

• 2 recalls, same reason

  • Terminated Z-2327-2009 FDA Unclassified (pre-2012) ·initiated 12 Feb 2009
  • Terminated Z-2326-2009 FDA Unclassified (pre-2012) ·initiated 12 Feb 2009

  Labeled with extended expiration date (24 months instead of 18 months)

510(k) Number

K070383 ↗

FDA Product Code

JFY

FDA applicant

Diagnostic Chemicals , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Unsaturated Iron Binding Capacity (Uibc) Assay

  Class I

  FDA 510(k) K963116 Active Cleared 20 Aug 1996

• Creatine Kinase-Sl Assay, Catalogue Number 326-10, 326-30

  Class II

  FDA 510(k) K973999 Active Cleared 11 Mar 1998

• Alkaline Phosphatase-Sl Assay Catalogue Number 309-10, 309-30

  Class II

  FDA 510(k) K980316 Active Cleared 12 Feb 1998

• Hdl/Ldl-Advance Calibrator, Cat. No. Se-278

  Class II

  FDA 510(k) K041926 Active Cleared 23 Nov 2004

• Urea-L3K Assay, Catalogue Number 283-17/10/30/50

  Class II

  FDA 510(k) K993178 Active Cleared 18 Oct 1999

• Y-Glutamyltransferase-Sl Assay, Cataloge Number 324-10, 324-30

  Class I

  FDA 510(k) K974000 Active Cleared 4 Nov 1997

See all devices from Diagnostic Chemicals, Ltd. →