EML105 ELECTROLYTE METABOLITE ANALYZER— 510(k) K962334

Substantially Equivalent

Radiometer America, Inc.

FDA 510(k) clearance K962334 for EML105 ELECTROLYTE METABOLITE ANALYZER, Substantially Equivalent on 1996-10-24. Applicant: Radiometer America, Inc..

Clearance details

Applicant: Radiometer America, Inc.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1996-06-17
Decision date: 1996-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.