ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM— 510(k) K974818

Substantially Equivalent

Radiometer America, Inc.

FDA 510(k) clearance K974818 for ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM, Substantially Equivalent on 1998-01-16. Applicant: Radiometer America, Inc..

Clearance details

Applicant: Radiometer America, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 1997-12-23
Decision date: 1998-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, US

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Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

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.