AUTO DELFIA— 510(k) K935047

Substantially Equivalent

Wallac OY

FDA 510(k) clearance K935047 for AUTO DELFIA, Substantially Equivalent on 1994-05-23. Applicant: Wallac OY.

Clearance details

Applicant: Wallac OY
Product code: Code KHO
Advisory panel: Clinical Chemistry
Date received: 1993-10-21
Decision date: 1994-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Finland, FI

Download summary PDF View on FDA.gov ↗

Adverse events under product code KHO

product code KHO

Malfunction: 1,339
Total: 1,339

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.