SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT— 510(k) K000494

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K000494 for SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT, Substantially Equivalent on 2000-04-14. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LDP
Advisory panel: Clinical Toxicology
Date received: 2000-02-15
Decision date: 2000-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, 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.