STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL— 510(k) K864445

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K864445 for STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL, Substantially Equivalent on 1987-02-04. Applicant: Nova Biomedical Corp..

Clearance details

Applicant: Nova Biomedical Corp.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 1986-11-12
Decision date: 1987-02-04
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.