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FDA 510(k)

Stat Profile Prime Plus Analyzer System

K-Number: K180340 · 2018-09-26

ApplicantNova Biomedical Corporation
Decision Date2018-09-26
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Stat Profile Prime Plus 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 2018-09-26 under 510(k) number K180340. 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 Stat Profile Prime Plus Analyzer System?

Stat Profile Prime Plus Analyzer System is a medical device that received FDA 510(k) clearance on 2018-09-26. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K180340.

When did Stat Profile Prime Plus Analyzer System receive FDA 510(k) clearance?

Stat Profile Prime Plus Analyzer System received FDA 510(k) clearance on 2018-09-26, under 510(k) number K180340.

Who is the listed applicant for Stat Profile Prime Plus 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 Stat Profile Prime Plus Analyzer System?

The FDA product code for Stat Profile Prime Plus Analyzer System is CGA.

Related Clinical Trials

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.

NCT03262415PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose MonitorCOMPLETEDNCT05754281The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing SystemACTIVE_NOT_RECRUITING

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: 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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