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FDA 510(k)

LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.

K-Number: K130295 · 2013-06-21

ApplicantInfopia Co, Ltd.
Decision Date2013-06-21
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. is the device name listed in this FDA 510(k) record. The listed applicant is Infopia Co, Ltd.. It received FDA 510(k) clearance on 2013-06-21 under 510(k) number K130295. 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 LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.?

LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. is a medical device that received FDA 510(k) clearance on 2013-06-21. The listed applicant is Infopia Co, Ltd.. The 510(k) number is K130295.

When did LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. receive FDA 510(k) clearance?

LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. received FDA 510(k) clearance on 2013-06-21, under 510(k) number K130295.

Who is the listed applicant for LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.?

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

What is the FDA product code for LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.?

The FDA product code for LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. 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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