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FDA 510(k)

GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS

K-Number: K990649 · 1999-07-09

ApplicantBayer Corp.
Decision Date1999-07-09
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1999-07-09 under 510(k) number K990649. 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 GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS?

GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS is a medical device that received FDA 510(k) clearance on 1999-07-09. The listed applicant is Bayer Corp.. The 510(k) number is K990649.

When did GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS receive FDA 510(k) clearance?

GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS received FDA 510(k) clearance on 1999-07-09, under 510(k) number K990649.

Who is the listed applicant for GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS?

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 GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS?

The FDA product code for GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER 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 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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