QLT ABSOLUTE URINE-HCG PREGNANCY TEST— 510(k) K881806

Substantially Equivalent

Quadra Logic Technologies, Inc.

FDA 510(k) clearance K881806 for QLT ABSOLUTE URINE-HCG PREGNANCY TEST, Substantially Equivalent on 1988-08-02. Applicant: Quadra Logic Technologies, Inc..

Clearance details

Applicant: Quadra Logic Technologies, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1988-04-28
Decision date: 1988-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, 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.