ANI BIOCARD HCG TEST— 510(k) K923030

Substantially Equivalent

Ani OY

FDA 510(k) clearance K923030 for ANI BIOCARD HCG TEST, Substantially Equivalent on 1992-09-15. Applicant: Ani OY.

Clearance details

Applicant: Ani OY
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1992-06-23
Decision date: 1992-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada M1x 1b4, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.