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FDA 510(k)

NOVA 5 NA/K/C1 ALALYZER

K-Number: K915177 · 1992-01-27

ApplicantNova Biomedical Corp.
Decision Date1992-01-27
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA 5 NA/K/C1 ALALYZER 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 1992-01-27 under 510(k) number K915177. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA 5 NA/K/C1 ALALYZER?

NOVA 5 NA/K/C1 ALALYZER is a medical device that received FDA 510(k) clearance on 1992-01-27. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K915177.

When did NOVA 5 NA/K/C1 ALALYZER receive FDA 510(k) clearance?

NOVA 5 NA/K/C1 ALALYZER received FDA 510(k) clearance on 1992-01-27, under 510(k) number K915177.

Who is the listed applicant for NOVA 5 NA/K/C1 ALALYZER?

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 NOVA 5 NA/K/C1 ALALYZER?

The FDA product code for NOVA 5 NA/K/C1 ALALYZER is CEM.

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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

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Related Devices (Code: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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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