EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653— 510(k) K882719

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K882719 for EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653, Substantially Equivalent on 1988-08-08. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code LDP
Advisory panel: Clinical Toxicology
Date received: 1988-07-01
Decision date: 1988-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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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.