HELENA THROMBOPLASTIN REAGENT, MODIFICATION— 510(k) K905857

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K905857 for HELENA THROMBOPLASTIN REAGENT, MODIFICATION, Substantially Equivalent on 1991-02-27. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code GJS
Advisory panel: Hematology
Date received: 1990-12-14
Decision date: 1991-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, 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.