Enzymatic Mitochondrial Antibody (M2) Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K982121 ↗

FDA Product Code

DBM

FDA applicant

Trace Scientific , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.5090

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Alt Incorporating Dst

  Class I

  FDA 510(k) K961123 Active Cleared 25 Apr 1996

• Iron 5 X Conc Reagent

  Class I

  FDA 510(k) K904116 Active Cleared 27 Sep 1990

• Total Bilirubin Reagent - Dmso Method

  Class II

  FDA 510(k) K870364 Active Cleared 19 Aug 1987

• Alt (Gpt) Ifcc 2-Vial Reagent W/Pyridoxyl Phosphat

  Class I

  FDA 510(k) K891469 Active Cleared 4 Apr 1989

• Alp (Alkaline Phosphatase) Reagent

  Class II

  FDA 510(k) K860715 Active Cleared 24 Apr 1986

• Enzymatic Cholesterol Reagent (Single Vial)

  Class I

  FDA 510(k) K860717 Active Cleared 11 Apr 1986

See all devices from Trace Scientific, Ltd. →