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FDA 510(k)

VERDICT -II BAR/BZO

K-Number: K010561 · 2001-04-05

ApplicantMedtox Diagnostics, Inc.
Decision Date2001-04-05
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VERDICT -II BAR/BZO is the device name listed in this FDA 510(k) record. The listed applicant is Medtox Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K010561. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERDICT -II BAR/BZO?

VERDICT -II BAR/BZO is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Medtox Diagnostics, Inc.. The 510(k) number is K010561.

When did VERDICT -II BAR/BZO receive FDA 510(k) clearance?

VERDICT -II BAR/BZO received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010561.

Who is the listed applicant for VERDICT -II BAR/BZO?

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

What is the FDA product code for VERDICT -II BAR/BZO?

The FDA product code for VERDICT -II BAR/BZO is DIS.

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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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