ELECTROLYTE ANALYZER SERA-252— 510(k) K853405

Substantially Equivalent

Horiba Instruments, Inc.

FDA 510(k) clearance K853405 for ELECTROLYTE ANALYZER SERA-252, Substantially Equivalent on 1985-12-04. Applicant: Horiba Instruments, Inc..

Clearance details

Applicant: Horiba Instruments, Inc.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 1985-08-12
Decision date: 1985-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.