CLEARVIEW HCG SERUM/URINE— 510(k) K905741

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K905741 for CLEARVIEW HCG SERUM/URINE, Substantially Equivalent on 1991-05-15. Applicant: Unipath , Ltd..

Clearance details

Applicant: Unipath , Ltd.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1990-12-24
Decision date: 1991-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford Mk41 Oqg, GB

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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.