ACETAMINOPHEN STAT-PAK REAGENT SET— 510(k) K821969

Substantially Equivalent

Clin Tech Diagnostics Corp.

FDA 510(k) clearance K821969 for ACETAMINOPHEN STAT-PAK REAGENT SET, Substantially Equivalent on 1982-07-16. Applicant: Clin Tech Diagnostics Corp..

Clearance details

Applicant: Clin Tech Diagnostics Corp.
Product code: Code LDP
Advisory panel: Clinical Toxicology
Date received: 1982-07-01
Decision date: 1982-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.