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FDA 510(k)

NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

K-Number: K063821 · 2007-01-24

ApplicantNova Biomedical Corp.
Decision Date2007-01-24
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM 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 2007-01-24 under 510(k) number K063821. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM?

NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-24. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K063821.

When did NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM receive FDA 510(k) clearance?

NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM received FDA 510(k) clearance on 2007-01-24, under 510(k) number K063821.

Who is the listed applicant for NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM?

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 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM?

The FDA product code for NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM is CGA.

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Other records listing Nova Biomedical Corp. as applicant

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.

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: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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