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FDA 510(k)

SUPREME II METER

K-Number: K963544 · 1997-02-20

ApplicantChronimed, Inc.
Decision Date1997-02-20
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUPREME II METER is the device name listed in this FDA 510(k) record. The listed applicant is Chronimed, Inc.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K963544. 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 SUPREME II METER?

SUPREME II METER is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Chronimed, Inc.. The 510(k) number is K963544.

When did SUPREME II METER receive FDA 510(k) clearance?

SUPREME II METER received FDA 510(k) clearance on 1997-02-20, under 510(k) number K963544.

Who is the listed applicant for SUPREME II METER?

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

What is the FDA product code for SUPREME II METER?

The FDA product code for SUPREME II METER is CGA.

Related Clinical Trials

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.

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Other records listing Chronimed, 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.

K010039QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTIONK983432SUPREME II CONTROL SOLUTIONSK980573SENSOREX BLOOD GLUCOSE MONITORING SYSTEMK981555DIASCREEN REAGENT STRIPS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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