ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10— 510(k) K980031

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K980031 for ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10, Substantially Equivalent on 1998-03-03. Applicant: Diagnostic Chemicals , Ltd..

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: 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

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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.