ACA PROTHROMBIN TIME ANALYTICAL TEST PACK— 510(k) K851125

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K851125 for ACA PROTHROMBIN TIME ANALYTICAL TEST PACK, Substantially Equivalent on 1985-05-29. Applicant: E.I. Dupont DE Nemours & Co., Inc..

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code GJS
Advisory panel: Hematology
Date received: 1985-03-19
Decision date: 1985-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, 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.