HEMOCHRON RESPONSE/SYSTEM— 510(k) K030818

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K030818 for HEMOCHRON RESPONSE/SYSTEM, Substantially Equivalent on 2003-04-02. Applicant: International Technidyne Corp..

Clearance details

Applicant: International Technidyne Corp.
Product code: Code JPA
Advisory panel: Hematology
Date received: 2003-03-14
Decision date: 2003-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Edison, NJ, US

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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.