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FDA 510(k)

STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS

K-Number: K960120 · 1996-03-11

ApplicantNova Biomedical Corp.
Decision Date1996-03-11
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS 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 1996-03-11 under 510(k) number K960120. The device is classified under product code JFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS?

STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K960120.

When did STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS receive FDA 510(k) clearance?

STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS received FDA 510(k) clearance on 1996-03-11, under 510(k) number K960120.

Who is the listed applicant for STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS?

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 F,G,H,I,J, AND K ANALYZERS?

The FDA product code for STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS is JFP.

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Other records listing Nova Biomedical Corp. as applicant

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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: JFP)

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.

K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical CorporationK152327EasyLyte Na/K/Cl/Ca AnalyzerMedica CorporationK984299AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.K972673AVL 9181 ELECTROLYTE ANALYZERAvl Scientific Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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