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FDA 510(k)

EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005

K-Number: K082121 · 2008-09-17

ApplicantEps Bio Technology Corp.
Decision Date2008-09-17
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 is the device name listed in this FDA 510(k) record. The listed applicant is Eps Bio Technology Corp.. It received FDA 510(k) clearance on 2008-09-17 under 510(k) number K082121. 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 EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005?

EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 is a medical device that received FDA 510(k) clearance on 2008-09-17. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K082121.

When did EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 receive FDA 510(k) clearance?

EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 received FDA 510(k) clearance on 2008-09-17, under 510(k) number K082121.

Who is the listed applicant for EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005?

The FDA 510(k) record lists Eps Bio Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005?

The FDA product code for EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 is CGA.

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Other records listing Eps Bio Technology Corp. as applicant

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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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