NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM— 510(k) K131703

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K131703 for NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM, Substantially Equivalent on 2014-03-25. Applicant: Nova Biomedical Corporation.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2013-06-11
Decision date: 2014-03-25
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.