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FDA 510(k)

GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS

K-Number: K102816 · 2011-09-15

ApplicantApex BioTechnology Corp.
Decision Date2011-09-15
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2011-09-15 under 510(k) number K102816. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS?

GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K102816.

When did GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS receive FDA 510(k) clearance?

GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS received FDA 510(k) clearance on 2011-09-15, under 510(k) number K102816.

Who is the listed applicant for GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS?

The FDA product code for GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS is NBW. This falls under the OB/GYN category.

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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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