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FDA 510(k)

TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS

K-Number: K030703 · 2003-07-11

ApplicantHome Diagnostics, Inc.
Decision Date2003-07-11
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS 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 2003-07-11 under 510(k) number K030703. 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 TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS?

TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS is a medical device that received FDA 510(k) clearance on 2003-07-11. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K030703.

When did TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS receive FDA 510(k) clearance?

TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS received FDA 510(k) clearance on 2003-07-11, under 510(k) number K030703.

Who is the listed applicant for TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS?

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 TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS?

The FDA product code for TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS is NBW. This falls under the OB/GYN category.

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Other records listing Home Diagnostics, Inc. as applicant

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K090495TRUEBALANCE BLOOD GLUCOSE SYSTEMK080641TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81K080710TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81K070593TRACKRECORD DATA MANAGEMENT SOFTWAREK060793ELEMENT BLOOD GLUCOSE TEST SYSTEMK051147SIDEKICK BLOOD GLUCOSE TEST SYSTEM

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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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