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FDA 510(k)

SENOVA(R) BLOOD GLUCOSE MONITOR

K-Number: K032076 · 2003-09-30

ApplicantChdiagnostics, LLC
Decision Date2003-09-30
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SENOVA(R) BLOOD GLUCOSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Chdiagnostics, LLC. It received FDA 510(k) clearance on 2003-09-30 under 510(k) number K032076. 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 SENOVA(R) BLOOD GLUCOSE MONITOR?

SENOVA(R) BLOOD GLUCOSE MONITOR is a medical device that received FDA 510(k) clearance on 2003-09-30. The listed applicant is Chdiagnostics, LLC. The 510(k) number is K032076.

When did SENOVA(R) BLOOD GLUCOSE MONITOR receive FDA 510(k) clearance?

SENOVA(R) BLOOD GLUCOSE MONITOR received FDA 510(k) clearance on 2003-09-30, under 510(k) number K032076.

Who is the listed applicant for SENOVA(R) BLOOD GLUCOSE MONITOR?

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

What is the FDA product code for SENOVA(R) BLOOD GLUCOSE MONITOR?

The FDA product code for SENOVA(R) BLOOD GLUCOSE 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.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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