Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)— 510(k) K142220

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K142220 for Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators), Substantially Equivalent on 2014-10-17. Applicant: Nova Biomedical Corporation.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2014-08-12
Decision date: 2014-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, 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.