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FDA 510(k)

NOVA 16 ANALYZER

K-Number: K945584 · 1995-02-08

ApplicantNova Biomedical Corp.
Decision Date1995-02-08
Product CodeJJC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA 16 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 1995-02-08 under 510(k) number K945584. The device is classified under product code JJC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA 16 ANALYZER?

NOVA 16 ANALYZER is a medical device that received FDA 510(k) clearance on 1995-02-08. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K945584.

When did NOVA 16 ANALYZER receive FDA 510(k) clearance?

NOVA 16 ANALYZER received FDA 510(k) clearance on 1995-02-08, under 510(k) number K945584.

Who is the listed applicant for NOVA 16 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 NOVA 16 ANALYZER?

The FDA product code for NOVA 16 ANALYZER is JJC.

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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: JJC)

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.

K945915AVL OMNI ANALYZERAvl Scientific Corp.K943376OPERA SYSTEMMiles, Inc.K901410TECHNICON RA-2000(TM) SYSTEMTechnicon Instruments Corp.K901141PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZXBaxter Healthcare CorpK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTERAlpkem Corp.K881056AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030American Research Products Co.

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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