BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT— 510(k) K013062

Substantially Equivalent

Biocheck, Inc.

FDA 510(k) clearance K013062 for BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT, Substantially Equivalent on 2002-01-08. Applicant: Biocheck, Inc..

Clearance details

Applicant: Biocheck, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2001-09-12
Decision date: 2002-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

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Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.