DELFIA HTSH ULTRA KIT— 510(k) K923401

Substantially Equivalent

Wallac OY

FDA 510(k) clearance K923401 for DELFIA HTSH ULTRA KIT, Substantially Equivalent on 1992-11-30. Applicant: Wallac OY.

Clearance details

Applicant: Wallac OY
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1992-07-10
Decision date: 1992-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Finland, FI

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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.