POLY STAT HCG DIPSTICK TEST— 510(k) K021386

Substantially Equivalent

Alidex, Inc.

FDA 510(k) clearance K021386 for POLY STAT HCG DIPSTICK TEST, Substantially Equivalent on 2002-08-05. Applicant: Alidex, Inc..

Clearance details

Applicant: Alidex, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 2002-05-02
Decision date: 2002-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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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.