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FDA 510(k)

ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K110637 · 2011-09-07

ApplicantCilag GmbH International
Decision Date2011-09-07
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cilag GmbH International. It received FDA 510(k) clearance on 2011-09-07 under 510(k) number K110637. 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 ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM?

ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-07. The listed applicant is Cilag GmbH International. The 510(k) number is K110637.

When did ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2011-09-07, under 510(k) number K110637.

Who is the listed applicant for ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM?

The FDA 510(k) record lists Cilag GmbH International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM is LFR.

Related Clinical Trials

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Other records listing Cilag GmbH International 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.

K131363ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMK120708ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM

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.K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical CorporationK121433GOODLIFE 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 Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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