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FDA 510(k)

NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM

K-Number: K110648 · 2011-08-29

ApplicantNova Biomedical Corporation
Decision Date2011-08-29
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corporation. It received FDA 510(k) clearance on 2011-08-29 under 510(k) number K110648. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM?

NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-29. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K110648.

When did NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM receive FDA 510(k) clearance?

NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM received FDA 510(k) clearance on 2011-08-29, under 510(k) number K110648.

Who is the listed applicant for NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM?

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

What is the FDA product code for NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM?

The FDA product code for NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM is CHL.

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Other records listing Nova Biomedical Corporation 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.

K251281Nova Max Creat eGFR Monitoring SystemK252206Nova Allegro UACR Assay, Nova Allegro AnalyzerK221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerK221813Nova Allegro UACR Assay, Nova Allegro AnalyzerK232075StatStrip Glucose Hospital Meter SystemK221900Stat Profile Prime Plus Analyzer System

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Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ 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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