HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION— 510(k) K930068

Substantially Equivalent

Technidyne Corp.

FDA 510(k) clearance K930068 for HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION, Substantially Equivalent on 1993-09-02. Applicant: Technidyne Corp..

Clearance details

Applicant: Technidyne Corp.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1993-01-06
Decision date: 1993-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
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.