FDA 510(k)

VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS

K-Number: K123016 · 2013-06-18

Decision Date2013-06-18

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Mico Biomed Co., Ltd.. It received FDA 510(k) clearance on 2013-06-18 under 510(k) number K123016. 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 VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS?

VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS is a medical device that received FDA 510(k) clearance on 2013-06-18. The listed applicant is Mico Biomed Co., Ltd.. The 510(k) number is K123016.

When did VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS receive FDA 510(k) clearance?

VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS received FDA 510(k) clearance on 2013-06-18, under 510(k) number K123016.

Who is the listed applicant for VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS?

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

What is the FDA product code for VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS?

The FDA product code for VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS is NBW. This falls under the OB/GYN category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.