Biocheck Human Cardiac Troponin-I Immunoassay Test Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K013062 ↗

FDA Product Code

MMI

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Biocheck Hcg Enzyme Immunoassay Test Kit, Model Bc-1027

  Class II

  FDA 510(k) K991741 Active Cleared 22 Jul 1999

• Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model Bc-1119

  Class II

  FDA 510(k) K003851 Active Cleared 20 Jul 2001

• Biocheck IgE ELISA, Model BC-1035

  Class II

  FDA 510(k) K992528 Active Cleared 21 Sep 1999

• Biocheck Ferritin Elisa Model Bc-1025

  Class II

  FDA 510(k) K992517 Active Cleared 24 Sep 1999

• Biocheck Cardiac-1 Crp Rapid Test, Model Bc-804114

  Class II

  FDA 510(k) K040030 Active Cleared 16 Jun 2004

• Biocheck Testosterone Eia, Model Bc-1115

  Class I

  FDA 510(k) K002294 Active Cleared 2 Oct 2000

See all devices from Biocheck, Inc. →

• What is the Biocheck Human Cardiac Troponin-I Immunoassay Test Kit used for?

  The Biocheck Human Cardiac Troponin-I Immunoassay Test Kit is used to assist in the diagnosis of acute myocardial infarction by measuring cardiac troponin I levels in patient serum samples.

• Is the Biocheck Human Cardiac Troponin-I Immunoassay Test Kit supplied for single or multiple uses?

  The test kit is supplied as a single product for use in clinical laboratory settings by trained personnel.

• What is the regulatory status of the Biocheck Human Cardiac Troponin-I Immunoassay Test Kit?

  The device has been cleared with the FDA 510K authorization, with the decision description being substantially equivalent.

• What type of setting is the Biocheck Human Cardiac Troponin-I Immunoassay Test Kit intended for?

  The test kit is intended for use in clinical laboratory settings by trained personnel.