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FDA 510(k)

GLUCOCHEK

K-Number: K940215 · 1995-01-17

ApplicantClinical Diagnostics, Inc.
Decision Date1995-01-17
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOCHEK is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-01-17 under 510(k) number K940215. 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 GLUCOCHEK?

GLUCOCHEK is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Clinical Diagnostics, Inc.. The 510(k) number is K940215.

When did GLUCOCHEK receive FDA 510(k) clearance?

GLUCOCHEK received FDA 510(k) clearance on 1995-01-17, under 510(k) number K940215.

Who is the listed applicant for GLUCOCHEK?

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

What is the FDA product code for GLUCOCHEK?

The FDA product code for GLUCOCHEK is CGA.

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Other records listing Clinical Diagnostics, 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.

K971653GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEMK951457GLUCOCHEK POCKETLABK854903GORDON DIAGNOSTIC SYSTEM MODEL IK771813CENTRIFICHEM SYS 400 ANALYZERK771118CENTRIA SEPARATION COLUMNS TYPE AK771117CENTRIA CORTISOL RIA

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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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