FDA 510(k)

MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL

K-Number: K040670 · 2004-03-25

Decision Date2004-03-25

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL 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 2004-03-25 under 510(k) number K040670. 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 MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL?

MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL is a medical device that received FDA 510(k) clearance on 2004-03-25. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K040670.

When did MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL receive FDA 510(k) clearance?

MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL received FDA 510(k) clearance on 2004-03-25, under 510(k) number K040670.

Who is the listed applicant for MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL?

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 MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL?

The FDA product code for MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL 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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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.