IRMA BLOOD ANALYSIS SYSTEM— 510(k) K945240

Substantially Equivalent

Diametrics Medical, Inc.

FDA 510(k) clearance K945240 for IRMA BLOOD ANALYSIS SYSTEM, Substantially Equivalent on 1995-01-05. Applicant: Diametrics Medical, Inc..

Clearance details

Applicant: Diametrics Medical, Inc.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 1994-10-27
Decision date: 1995-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, MN, US

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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.