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FDA 510(k)

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001

K-Number: K053079 · 2006-03-28

ApplicantHypoguard USA, Inc.
Decision Date2006-03-28
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 is the device name listed in this FDA 510(k) record. The listed applicant is Hypoguard USA, Inc.. It received FDA 510(k) clearance on 2006-03-28 under 510(k) number K053079. 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 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001?

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 is a medical device that received FDA 510(k) clearance on 2006-03-28. The listed applicant is Hypoguard USA, Inc.. The 510(k) number is K053079.

When did ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 receive FDA 510(k) clearance?

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 received FDA 510(k) clearance on 2006-03-28, under 510(k) number K053079.

Who is the listed applicant for ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001?

The FDA 510(k) record lists Hypoguard USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001?

The FDA product code for ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 is CGA.

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Other records listing Hypoguard USA, 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.

K051514ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002K041881ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100K033851DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)K031388MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEMK024347EXPRESS BLOOD GLUCOSE MONITORING SYSTEMK022545GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020

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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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