Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STAT PROFILE M7 ANALYZER

K-Number: K991727 · 1999-07-16

ApplicantNova Biomedical Corp.
Decision Date1999-07-16
Product CodeCGL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAT PROFILE M7 ANALYZER 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 1999-07-16 under 510(k) number K991727. The device is classified under product code CGL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT PROFILE M7 ANALYZER?

STAT PROFILE M7 ANALYZER is a medical device that received FDA 510(k) clearance on 1999-07-16. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K991727.

When did STAT PROFILE M7 ANALYZER receive FDA 510(k) clearance?

STAT PROFILE M7 ANALYZER received FDA 510(k) clearance on 1999-07-16, under 510(k) number K991727.

Who is the listed applicant for STAT PROFILE M7 ANALYZER?

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 STAT PROFILE M7 ANALYZER?

The FDA product code for STAT PROFILE M7 ANALYZER is CGL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 89 devices →

Related Devices (Code: CGL)

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.

K261039i-STAT Crea cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K171059Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical CorporationK113726EPOC CHLORIDE TEST AND EPOC CREATININE TESTEpocal, Inc.K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSNova Biomedical Corp.K051968ABL8X7 FLEXRadiometer Medical ApsK973292I-STAT SYSTEMI-Stat Corp.

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.

↑