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FDA 510(k)

HEMOCUE B-GLUCOSE SYSTEM

K-Number: K961311 · 1996-08-23

ApplicantHemocue, Inc.
Decision Date1996-08-23
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMOCUE B-GLUCOSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemocue, Inc.. It received FDA 510(k) clearance on 1996-08-23 under 510(k) number K961311. 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 HEMOCUE B-GLUCOSE SYSTEM?

HEMOCUE B-GLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-23. The listed applicant is Hemocue, Inc.. The 510(k) number is K961311.

When did HEMOCUE B-GLUCOSE SYSTEM receive FDA 510(k) clearance?

HEMOCUE B-GLUCOSE SYSTEM received FDA 510(k) clearance on 1996-08-23, under 510(k) number K961311.

Who is the listed applicant for HEMOCUE B-GLUCOSE SYSTEM?

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

What is the FDA product code for HEMOCUE B-GLUCOSE SYSTEM?

The FDA product code for HEMOCUE B-GLUCOSE SYSTEM is LFR.

Related Clinical Trials

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Other records listing Hemocue, 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.

K041234HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEMK041230CLINICAL LABORATORY ANALYZING SYSTEMK032203HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704K020935HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706K962415HEMOCUE B-GLCOSE SYSTEMK961312HEMOCUE B-HEMOGLOBIN SYSTEM

View all 9 devices →

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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