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FDA 510(k)

ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS

K-Number: K091102 · 2009-10-23

ApplicantArkray Factory USA, Inc.
Decision Date2009-10-23
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Arkray Factory USA, Inc.. It received FDA 510(k) clearance on 2009-10-23 under 510(k) number K091102. 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 ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS?

ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Arkray Factory USA, Inc.. The 510(k) number is K091102.

When did ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS receive FDA 510(k) clearance?

ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS received FDA 510(k) clearance on 2009-10-23, under 510(k) number K091102.

Who is the listed applicant for ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS?

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

What is the FDA product code for ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS?

The FDA product code for ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS is CGA.

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Other records listing Arkray Factory USA, 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.

K110709ARK CARE DIABETES MANAGMENT SYSTEMK093819ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)K092104ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMK090653POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEMK090332ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001K082417GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110

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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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