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FDA 510(k)

IGLUCOSE SYSTEM

K-Number: K111932 · 2011-11-10

ApplicantPositiveid Corporation
Decision Date2011-11-10
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IGLUCOSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Positiveid Corporation. It received FDA 510(k) clearance on 2011-11-10 under 510(k) number K111932. 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 IGLUCOSE SYSTEM?

IGLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Positiveid Corporation. The 510(k) number is K111932.

When did IGLUCOSE SYSTEM receive FDA 510(k) clearance?

IGLUCOSE SYSTEM received FDA 510(k) clearance on 2011-11-10, under 510(k) number K111932.

Who is the listed applicant for IGLUCOSE SYSTEM?

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

What is the FDA product code for IGLUCOSE SYSTEM?

The FDA product code for IGLUCOSE SYSTEM 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.

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