POSITIVE AND NEGATIVE HCG URINE CONTROLS— 510(k) K894181

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K894181 for POSITIVE AND NEGATIVE HCG URINE CONTROLS, Substantially Equivalent on 1989-08-31. Applicant: Armkel, LLC.

Clearance details

Applicant: Armkel, LLC
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1989-06-16
Decision date: 1989-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, 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.