HEMOSIL PT-FIBRINOGEN HS PLUS— 510(k) K060931

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K060931 for HEMOSIL PT-FIBRINOGEN HS PLUS, Substantially Equivalent on 2006-05-02. Applicant: Instrumentation Laboratory CO.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GJS
Advisory panel: Hematology
Date received: 2006-04-05
Decision date: 2006-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.