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FDA 510(k)

GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K102316 · 2011-10-07

ApplicantBroadmaster Biotech Corporation
Decision Date2011-10-07
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Broadmaster Biotech Corporation. It received FDA 510(k) clearance on 2011-10-07 under 510(k) number K102316. 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 GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM?

GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-07. The listed applicant is Broadmaster Biotech Corporation. The 510(k) number is K102316.

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

GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2011-10-07, under 510(k) number K102316.

Who is the listed applicant for GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM?

The FDA 510(k) record lists Broadmaster Biotech Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM is CGA.

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Other records listing Broadmaster Biotech Corporation 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.

K130621BROADMASTER HEALTHCARE SYSTEM

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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