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FDA 510(k)

BETACHEK GLUCOSE TEST

K-Number: K062187 · 2009-03-24

ApplicantNational Diagnostic Products
Decision Date2009-03-24
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BETACHEK GLUCOSE TEST is the device name listed in this FDA 510(k) record. The listed applicant is National Diagnostic Products. It received FDA 510(k) clearance on 2009-03-24 under 510(k) number K062187. 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 BETACHEK GLUCOSE TEST?

BETACHEK GLUCOSE TEST is a medical device that received FDA 510(k) clearance on 2009-03-24. The listed applicant is National Diagnostic Products. The 510(k) number is K062187.

When did BETACHEK GLUCOSE TEST receive FDA 510(k) clearance?

BETACHEK GLUCOSE TEST received FDA 510(k) clearance on 2009-03-24, under 510(k) number K062187.

Who is the listed applicant for BETACHEK GLUCOSE TEST?

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

What is the FDA product code for BETACHEK GLUCOSE TEST?

The FDA product code for BETACHEK GLUCOSE TEST is NBW. This falls under the OB/GYN category.

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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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