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FDA 510(k)

TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM

K-Number: K042080 · 2004-08-19

ApplicantHome Diagnostics, Inc.
Decision Date2004-08-19
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM 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 2004-08-19 under 510(k) number K042080. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM?

TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-19. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K042080.

When did TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM receive FDA 510(k) clearance?

TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM received FDA 510(k) clearance on 2004-08-19, under 510(k) number K042080.

Who is the listed applicant for TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM?

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 TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM?

The FDA product code for TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM is JJX.

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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 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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Related Devices (Code: JJX)

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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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