MDA SIMPLASTIN HTF— 510(k) K974566

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K974566 for MDA SIMPLASTIN HTF, Substantially Equivalent on 1998-02-24. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code GJS
Advisory panel: Hematology
Date received: 1997-12-05
Decision date: 1998-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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.