IL TEST PT-FIBRINOGEN RECOMBINANT— 510(k) K981479

Name: FDA 510(k) clearance K981479
Creator: U.S. Food and Drug Administration
Published: 1998-07-07

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K981479 for IL TEST PT-FIBRINOGEN RECOMBINANT, Substantially Equivalent on 1998-07-07. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1998-04-24
Decision date: 1998-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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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.