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FDA 510(k)

NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS

K-Number: K112638 · 2012-03-09

ApplicantNova Biomedical Corporation
Decision Date2012-03-09
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS 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 2012-03-09 under 510(k) number K112638. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS?

NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS is a medical device that received FDA 510(k) clearance on 2012-03-09. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K112638.

When did NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS receive FDA 510(k) clearance?

NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS received FDA 510(k) clearance on 2012-03-09, under 510(k) number K112638.

Who is the listed applicant for NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS?

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 ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS?

The FDA product code for NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS is NBW. This falls under the OB/GYN category.

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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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