EDL ONE-STAGE PROTHROMBIN TIME REAGENT— 510(k) K891370

Substantially Equivalent

Elite Diagnostic , Ltd.

FDA 510(k) clearance K891370 for EDL ONE-STAGE PROTHROMBIN TIME REAGENT, Substantially Equivalent on 1989-04-21. Applicant: Elite Diagnostic , Ltd..

Clearance details

Applicant: Elite Diagnostic , Ltd.
Product code: Code GJS
Advisory panel: Hematology
Date received: 1989-03-09
Decision date: 1989-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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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.