FDA 510(k)

GLUCOMETER DEX TEST SENSOR

K-Number: K012205 · 2001-09-12

Decision Date2001-09-12

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOMETER DEX TEST SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2001-09-12 under 510(k) number K012205. 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 DEX TEST SENSOR?

GLUCOMETER DEX TEST SENSOR is a medical device that received FDA 510(k) clearance on 2001-09-12. The listed applicant is Bayer Corp.. The 510(k) number is K012205.

When did GLUCOMETER DEX TEST SENSOR receive FDA 510(k) clearance?

GLUCOMETER DEX TEST SENSOR received FDA 510(k) clearance on 2001-09-12, under 510(k) number K012205.

Who is the listed applicant for GLUCOMETER DEX TEST SENSOR?

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 DEX TEST SENSOR?

The FDA product code for GLUCOMETER DEX TEST SENSOR is NBW. This falls under the OB/GYN category.

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Other records listing Bayer Corp. as applicant

K024062ASCENSIA BREEZE BLOOD GLUCOSE METER K023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST K024017BAYER ADVIA CENTAUR HER-2/NEU ASSAY K024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM K023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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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.