GENESIS B-HCG— 510(k) K823753

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K823753 for GENESIS B-HCG, Substantially Equivalent on 1983-01-24. Applicant: Armkel, LLC.

Clearance details

Applicant: Armkel, LLC
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1982-12-14
Decision date: 1983-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.