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FDA 510(k)

NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL

K-Number: K913259 · 1991-10-08

ApplicantNova Biomedical Corp.
Decision Date1991-10-08
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corp.. It received FDA 510(k) clearance on 1991-10-08 under 510(k) number K913259. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL?

NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL is a medical device that received FDA 510(k) clearance on 1991-10-08. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K913259.

When did NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL receive FDA 510(k) clearance?

NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL received FDA 510(k) clearance on 1991-10-08, under 510(k) number K913259.

Who is the listed applicant for NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL?

The FDA 510(k) record lists Nova Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL?

The FDA product code for NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL is GKZ.

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K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSK101633NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGHK091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOSK070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEMK070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

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Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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