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FDA 510(k)

NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS

K-Number: K884618 · 1989-01-24

ApplicantNova Biomedical Corp.
Decision Date1989-01-24
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS 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 1989-01-24 under 510(k) number K884618. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS?

NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K884618.

When did NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS receive FDA 510(k) clearance?

NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS received FDA 510(k) clearance on 1989-01-24, under 510(k) number K884618.

Who is the listed applicant for NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS?

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 11 AUTO. HEMA. ANALYZER, CALIBRATORS?

The FDA product code for NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS is GKL.

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Other records listing Nova Biomedical Corp. as applicant

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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: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex 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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