Trace Reagent Line for the Cobas Mira

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K973869 ↗

FDA Product Code

CKA

Device Class

Class I

Regulation

21 CFR Part 862.1030

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• 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

• Glucose (Hk) - Incorporating Dynamic Stabilization Technology - (Dst)

  Class II

  FDA 510(k) K980026 Active Cleared 10 Mar 1998

See all devices from Trace America, Inc. →