Ammonia-Incorporating Dynamic Stabilization Technology (Dst)

• • Terminated Z-0015-2008 FDA Unclassified (pre-2012) ·initiated 24 Jul 2007

  Method is susceptible to positive interference from endogenous ALT in patient samples.

510(k) Number

K974620 ↗

FDA Product Code

JIF

Device Class

Class I

Regulation

21 CFR Part 862.1065

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Trace Reagent Line for the Cobas Mira

  Class I

  FDA 510(k) K973869 Active Cleared 7 Jan 1998

• AST (GOT) Liquid Stable 2 Vial - Dynamic Stabilization Technology (DST)

  Class II

  FDA 510(k) K980030 Active Cleared 30 Jan 1998

• Trace Hdl Cholesterol - Automated (Homogen

  Class I

  FDA 510(k) K962723 Active Cleared 13 Mar 1997

• Resubmitted Bicarbonate (CO2) Reagent Single Vial

  Class II

  FDA 510(k) K880794 Active Cleared 18 Apr 1988

• Resubmitted Alkaline Phosphatase Reagent Amp Buff.

  Class II

  FDA 510(k) K880795 Active Cleared 18 Apr 1988

• Porphobilinogen (Pbg)

  Class I

  FDA 510(k) K961984 Active Cleared 10 Dec 1996

See all devices from Trace America, Inc. →