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FDA 510(k)

GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110

K-Number: K082417 · 2008-10-21

ApplicantArkray Factory USA, Inc.
Decision Date2008-10-21
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 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 2008-10-21 under 510(k) number K082417. 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 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110?

GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 is a medical device that received FDA 510(k) clearance on 2008-10-21. The listed applicant is Arkray Factory USA, Inc.. The 510(k) number is K082417.

When did GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 receive FDA 510(k) clearance?

GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 received FDA 510(k) clearance on 2008-10-21, under 510(k) number K082417.

Who is the listed applicant for GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110?

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 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110?

The FDA product code for GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 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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