POSITIVE & NEGATIVE HCG URINE CONTROLS— 510(k) K821742

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K821742 for POSITIVE & NEGATIVE HCG URINE CONTROLS, Substantially Equivalent on 1982-07-02. Applicant: Armkel, LLC.

Clearance details

Applicant: Armkel, LLC
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1982-06-14
Decision date: 1982-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.