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FDA 510(k)

GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM

K-Number: K971653 · 1998-01-02

ApplicantClinical Diagnostics, Inc.
Decision Date1998-01-02
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM 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 1998-01-02 under 510(k) number K971653. 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 POCKETLAB II BLOOD GLUCOSE SYSTEM?

GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-02. The listed applicant is Clinical Diagnostics, Inc.. The 510(k) number is K971653.

When did GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM receive FDA 510(k) clearance?

GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM received FDA 510(k) clearance on 1998-01-02, under 510(k) number K971653.

Who is the listed applicant for GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM?

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 POCKETLAB II BLOOD GLUCOSE SYSTEM?

The FDA product code for GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM 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.

K951457GLUCOCHEK POCKETLABK940215GLUCOCHEKK854903GORDON 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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