NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL— 510(k) K913259

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K913259 for NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL, Substantially Equivalent on 1991-10-08. Applicant: Nova Biomedical Corp..

Clearance details

Applicant: Nova Biomedical Corp.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1991-07-23
Decision date: 1991-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, US

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Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

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.