K980031

Substantially Equivalent

ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10

Applicant: Diagnostic Chemicals , Ltd.
Product code: LDP
Advisory panel: Clinical Toxicology
Date received: 1998-01-05
Decision date: 1998-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Adverse events under product code LDP

product code LDP

Other: 1
Total: 1

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.