BETA-TEC QUALITATIVE— 510(k) K802999

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K802999 for BETA-TEC QUALITATIVE, Substantially Equivalent on 1980-12-22. Applicant: Armkel, LLC.

Clearance details

Applicant: Armkel, LLC
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1980-11-25
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.