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FDA 510(k)

ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM

K-Number: K073416 · 2008-06-13

ApplicantArkray Factory USA, Inc.
Decision Date2008-06-13
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM 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 2008-06-13 under 510(k) number K073416. 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 ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM?

ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-13. The listed applicant is Arkray Factory USA, Inc.. The 510(k) number is K073416.

When did ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM receive FDA 510(k) clearance?

ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM received FDA 510(k) clearance on 2008-06-13, under 510(k) number K073416.

Who is the listed applicant for ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM?

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 ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM?

The FDA product code for ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM is CGA.

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Other records listing Arkray Factory USA, Inc. 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.

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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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