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FDA 510(k)

NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR

K-Number: K122688 · 2013-04-04

ApplicantNova Biomedical Corporation
Decision Date2013-04-04
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR 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 2013-04-04 under 510(k) number K122688. The device is classified under product code LFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR?

NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR is a medical device that received FDA 510(k) clearance on 2013-04-04. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K122688.

When did NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR receive FDA 510(k) clearance?

NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR received FDA 510(k) clearance on 2013-04-04, under 510(k) number K122688.

Who is the listed applicant for NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR?

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 MINI BLOOD GLUCOSE AND B-KETONE MONITOR?

The FDA product code for NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR is LFR.

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Related Devices (Code: LFR)

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.

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.K121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical CorporationK113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology CorporationK113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMHmd Biomedical, Inc.

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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