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FDA 510(k)

ULTRA BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K912440 · 1991-07-17

ApplicantHome Diagnostics, Inc.
Decision Date1991-07-17
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA BLOOD GLUCOSE MONITORING 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 1991-07-17 under 510(k) number K912440. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA BLOOD GLUCOSE MONITORING SYSTEM?

ULTRA BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K912440.

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

ULTRA BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 1991-07-17, under 510(k) number K912440.

Who is the listed applicant for ULTRA BLOOD GLUCOSE MONITORING 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 ULTRA BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ULTRA BLOOD GLUCOSE MONITORING SYSTEM is CGA.

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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: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

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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