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FDA 510(k)

GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)

K-Number: K020208 · 2002-04-29

ApplicantBayer Group Diagnostics
Decision Date2002-04-29
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Group Diagnostics. It received FDA 510(k) clearance on 2002-04-29 under 510(k) number K020208. 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 GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)?

GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) is a medical device that received FDA 510(k) clearance on 2002-04-29. The listed applicant is Bayer Group Diagnostics. The 510(k) number is K020208.

When did GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) receive FDA 510(k) clearance?

GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) received FDA 510(k) clearance on 2002-04-29, under 510(k) number K020208.

Who is the listed applicant for GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)?

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

What is the FDA product code for GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)?

The FDA product code for GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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Other records listing Bayer Group Diagnostics 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.

K020210GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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