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FDA 510(k)

HEMOCUE B-GLUCOSE SYSTEM

K-Number: K943432 · 1995-01-17

ApplicantHemocue, Inc.
Decision Date1995-01-17
Product CodeCGA
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 1995-01-17 under 510(k) number K943432. The device is classified under product code CGA. 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 1995-01-17. The listed applicant is Hemocue, Inc.. The 510(k) number is K943432.

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

HEMOCUE B-GLUCOSE SYSTEM received FDA 510(k) clearance on 1995-01-17, under 510(k) number K943432.

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 CGA.

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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

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Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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