ROTOR SYSTEMS A/S-400 & LA/S-400— 510(k) K850485

Substantially Equivalent

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

FDA 510(k) clearance K850485 for ROTOR SYSTEMS A/S-400 & LA/S-400, Substantially Equivalent on 1985-03-12. Applicant: E.I. Dupont DE Nemours & Co., Inc..

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JQC
Advisory panel: Clinical Chemistry
Date received: 1985-02-07
Decision date: 1985-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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Adverse events under product code JQC

product code JQC

Other: 1
Total: 1

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.