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FDA 510(k)

GLUCOSE TEST SYSTEM

K-Number: K113137 · 2012-01-06

ApplicantRoche Diagnostics
Decision Date2012-01-06
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2012-01-06 under 510(k) number K113137. 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 GLUCOSE TEST SYSTEM?

GLUCOSE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-06. The listed applicant is Roche Diagnostics. The 510(k) number is K113137.

When did GLUCOSE TEST SYSTEM receive FDA 510(k) clearance?

GLUCOSE TEST SYSTEM received FDA 510(k) clearance on 2012-01-06, under 510(k) number K113137.

Who is the listed applicant for GLUCOSE TEST SYSTEM?

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

What is the FDA product code for GLUCOSE TEST SYSTEM?

The FDA product code for GLUCOSE TEST 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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