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FDA 510(k)

TRUEBALANCE BLOOD GLUCOSE SYSTEM

K-Number: K090495 · 2009-03-27

ApplicantHome Diagnostics, Inc.
Decision Date2009-03-27
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRUEBALANCE 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 2009-03-27 under 510(k) number K090495. 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 TRUEBALANCE BLOOD GLUCOSE SYSTEM?

TRUEBALANCE BLOOD GLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-27. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K090495.

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

TRUEBALANCE BLOOD GLUCOSE SYSTEM received FDA 510(k) clearance on 2009-03-27, under 510(k) number K090495.

Who is the listed applicant for TRUEBALANCE 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 TRUEBALANCE BLOOD GLUCOSE SYSTEM?

The FDA product code for TRUEBALANCE BLOOD GLUCOSE SYSTEM 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.

K080641TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81K080710TRUE2GO 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)

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.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

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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