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FDA 510(k)

HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706

K-Number: K020935 · 2002-04-03

ApplicantHemocue, Inc.
Decision Date2002-04-03
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 is the device name listed in this FDA 510(k) record. The listed applicant is Hemocue, Inc.. It received FDA 510(k) clearance on 2002-04-03 under 510(k) number K020935. 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 GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706?

HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Hemocue, Inc.. The 510(k) number is K020935.

When did HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 receive FDA 510(k) clearance?

HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 received FDA 510(k) clearance on 2002-04-03, under 510(k) number K020935.

Who is the listed applicant for HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706?

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 GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706?

The FDA product code for HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 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 121704K962415HEMOCUE B-GLCOSE SYSTEMK961312HEMOCUE B-HEMOGLOBIN SYSTEMK961311HEMOCUE B-GLUCOSE 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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