DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM— 510(k) K941146

Substantially Equivalent

Dupont Medical Products

FDA 510(k) clearance K941146 for DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM, Substantially Equivalent on 1994-10-03. Applicant: Dupont Medical Products.

Clearance details

Applicant: Dupont Medical Products
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1994-03-10
Decision date: 1994-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.