ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT— 510(k) K852790

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K852790 for ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT, Substantially Equivalent on 1985-11-12. Applicant: Nova Biomedical Corp..

Clearance details

Applicant: Nova Biomedical Corp.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 1985-07-01
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, 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.