NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL

Counter, Differential Cell

NOVA BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Celltrak 12 Auto Multi-para Hema Analyzer/cal.

Pre-market Notification Details

Device IDK913259
510k NumberK913259
Device Name:NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL
ClassificationCounter, Differential Cell
Applicant NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham,  MA  02454 -9141
ContactPaul W Macdonald
CorrespondentPaul W Macdonald
NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham,  MA  02454 -9141
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-23
Decision Date1991-10-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.