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FDA 510(k)

ASCENSIA BREEZE BLOOD GLUCOSE METER

K-Number: K024062 · 2003-03-03

ApplicantBayer Corp.
Decision Date2003-03-03
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASCENSIA BREEZE BLOOD GLUCOSE METER is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2003-03-03 under 510(k) number K024062. 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 ASCENSIA BREEZE BLOOD GLUCOSE METER?

ASCENSIA BREEZE BLOOD GLUCOSE METER is a medical device that received FDA 510(k) clearance on 2003-03-03. The listed applicant is Bayer Corp.. The 510(k) number is K024062.

When did ASCENSIA BREEZE BLOOD GLUCOSE METER receive FDA 510(k) clearance?

ASCENSIA BREEZE BLOOD GLUCOSE METER received FDA 510(k) clearance on 2003-03-03, under 510(k) number K024062.

Who is the listed applicant for ASCENSIA BREEZE BLOOD GLUCOSE METER?

The FDA 510(k) record lists Bayer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASCENSIA BREEZE BLOOD GLUCOSE METER?

The FDA product code for ASCENSIA BREEZE BLOOD GLUCOSE METER is CGA.

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Other records listing Bayer Corp. 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.

K023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEMK020828CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM

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Related Devices (Code: CGA)

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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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