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FDA 510(k)

GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM

K-Number: K113307 · 2012-07-27

ApplicantHmd Biomedical, Inc.
Decision Date2012-07-27
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hmd Biomedical, Inc.. It received FDA 510(k) clearance on 2012-07-27 under 510(k) number K113307. 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 GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM?

GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Hmd Biomedical, Inc.. The 510(k) number is K113307.

When did GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM receive FDA 510(k) clearance?

GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM received FDA 510(k) clearance on 2012-07-27, under 510(k) number K113307.

Who is the listed applicant for GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM?

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

What is the FDA product code for GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM?

The FDA product code for GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM is LFR.

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Other records listing Hmd Biomedical, Inc. 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.

K212248GlucoLeader Enhance 2 Blood Glucose Monitoring SystemK182428GlucoLeader Enhance Blood Glucose Monitoring SystemK121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSK113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMK120064TEST, BLOOD GLUCOSE SYSTEMK032985GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

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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.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

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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