DISCRETE CLINICAL ANALYZER— 510(k) K834521

Substantially Equivalent

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

FDA 510(k) clearance K834521 for DISCRETE CLINICAL ANALYZER, Substantially Equivalent on 1984-02-27. Applicant: E.I. Dupont DE Nemours & Co., Inc..

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1983-12-21
Decision date: 1984-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.