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FDA 510(k)

BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)

K-Number: K113636 · 2013-03-08

ApplicantPhilosys Co., Ltd.
Decision Date2013-03-08
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) is the device name listed in this FDA 510(k) record. The listed applicant is Philosys Co., Ltd.. It received FDA 510(k) clearance on 2013-03-08 under 510(k) number K113636. 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 BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)?

BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) is a medical device that received FDA 510(k) clearance on 2013-03-08. The listed applicant is Philosys Co., Ltd.. The 510(k) number is K113636.

When did BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) receive FDA 510(k) clearance?

BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) received FDA 510(k) clearance on 2013-03-08, under 510(k) number K113636.

Who is the listed applicant for BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)?

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

What is the FDA product code for BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)?

The FDA product code for BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) is CGA.

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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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