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FDA 510(k)

Nova Max Uric Acid Monitoring System

K-Number: K160990 · 2017-04-11

ApplicantNova Biomedical Corporation
Decision Date2017-04-11
Product CodePTC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Nova Max Uric Acid Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corporation. It received FDA 510(k) clearance on 2017-04-11 under 510(k) number K160990. The device is classified under product code PTC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova Max Uric Acid Monitoring System?

Nova Max Uric Acid Monitoring System is a medical device that received FDA 510(k) clearance on 2017-04-11. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K160990.

When did Nova Max Uric Acid Monitoring System receive FDA 510(k) clearance?

Nova Max Uric Acid Monitoring System received FDA 510(k) clearance on 2017-04-11, under 510(k) number K160990.

Who is the listed applicant for Nova Max Uric Acid Monitoring System?

The FDA 510(k) record lists Nova Biomedical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nova Max Uric Acid Monitoring System?

The FDA product code for Nova Max Uric Acid Monitoring System is PTC.

Other records listing Nova Biomedical Corporation as applicant

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Related Devices (Code: PTC)

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.

K242209UASure II Blood Uric Acid Monitoring SystemApex BioTechnology Corp.K181675FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring SystemTaidoc Technology Corporation

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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