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FDA 510(k)

TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81

K-Number: K080641 · 2008-08-19

ApplicantHome Diagnostics, Inc.
Decision Date2008-08-19
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 is the device name listed in this FDA 510(k) record. The listed applicant is Home Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-08-19 under 510(k) number K080641. 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 TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81?

TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 is a medical device that received FDA 510(k) clearance on 2008-08-19. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K080641.

When did TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 receive FDA 510(k) clearance?

TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 received FDA 510(k) clearance on 2008-08-19, under 510(k) number K080641.

Who is the listed applicant for TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81?

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

What is the FDA product code for TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81?

The FDA product code for TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 is NBW. This falls under the OB/GYN category.

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Other records listing Home Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090495TRUEBALANCE BLOOD GLUCOSE SYSTEMK080710TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81K070593TRACKRECORD DATA MANAGEMENT SOFTWAREK060793ELEMENT BLOOD GLUCOSE TEST SYSTEMK051147SIDEKICK BLOOD GLUCOSE TEST SYSTEMK042080TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM

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Related Devices (Code: NBW)

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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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