CANWEST-PREGBLUE— 510(k) K854989

Substantially Equivalent

Canwest Medictex, Inc.

FDA 510(k) clearance K854989 for CANWEST-PREGBLUE, Substantially Equivalent on 1986-01-13. Applicant: Canwest Medictex, Inc..

Clearance details

Applicant: Canwest Medictex, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1985-12-12
Decision date: 1986-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver B.C., 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.