ACETAMINOPHEN SERUM TOX EIA ASSAY— 510(k) K961373

Name: FDA 510(k) clearance K961373
Creator: U.S. Food and Drug Administration
Published: 1996-07-08

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K961373 for ACETAMINOPHEN SERUM TOX EIA ASSAY, Substantially Equivalent on 1996-07-08. Applicant: Diagnostic Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code LDP
Device class: Class 2
Regulation: 21 CFR 862.3030
Advisory panel: Clinical Toxicology
Date received: 1996-04-09
Decision date: 1996-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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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.