DIRECT READOUT MODULE ACCESSORY— 510(k) K861412

Substantially Equivalent

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

FDA 510(k) clearance K861412 for DIRECT READOUT MODULE ACCESSORY, Substantially Equivalent on 1986-05-23. Applicant: E.I. Dupont DE Nemours & Co., Inc..

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 1986-04-15
Decision date: 1986-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.