510(k) K850992— PREGNA-ZYME

Substantially Equivalent

Armkel, LLC

Clearance details

Applicant: Armkel, LLC
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1985-03-11
Decision date: 1985-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

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.