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FDA 510(k)

NOVA 13 ANALYZER

K-Number: K912561 · 1991-09-11

ApplicantNova Biomedical Corp.
Decision Date1991-09-11
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA 13 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 1991-09-11 under 510(k) number K912561. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA 13 ANALYZER?

NOVA 13 ANALYZER is a medical device that received FDA 510(k) clearance on 1991-09-11. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K912561.

When did NOVA 13 ANALYZER receive FDA 510(k) clearance?

NOVA 13 ANALYZER received FDA 510(k) clearance on 1991-09-11, under 510(k) number K912561.

Who is the listed applicant for NOVA 13 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 13 ANALYZER?

The FDA product code for NOVA 13 ANALYZER is CGZ.

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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: CGZ)

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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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