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 ULTRA L ANALYZER QUALITY CONTROL MATERIALS

K-Number: K961938 · 1996-06-28

ApplicantNova Biomedical Corp.
Decision Date1996-06-28
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS 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 1996-06-28 under 510(k) number K961938. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS?

STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS is a medical device that received FDA 510(k) clearance on 1996-06-28. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K961938.

When did STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS receive FDA 510(k) clearance?

STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS received FDA 510(k) clearance on 1996-06-28, under 510(k) number K961938.

Who is the listed applicant for STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS?

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 ULTRA L ANALYZER QUALITY CONTROL MATERIALS?

The FDA product code for STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS is GJS.

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: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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.

↑