DESTINY MAX COAGULATION ANALYZER— 510(k) K083896

Name: FDA 510(k) clearance K083896
Creator: U.S. Food and Drug Administration
Published: 2009-07-02

Substantially Equivalent

Trinity Biotech

FDA 510(k) clearance K083896 for DESTINY MAX COAGULATION ANALYZER, Substantially Equivalent on 2009-07-02. Applicant: Trinity Biotech. Device class: 2.

Clearance details

Applicant: Trinity Biotech
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2008-12-29
Decision date: 2009-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

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.