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FDA 510(k)

PROFILE -ER

K-Number: K033334 · 2003-11-10

ApplicantMedtox Diagnostics, Inc.
Decision Date2003-11-10
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PROFILE -ER 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 2003-11-10 under 510(k) number K033334. 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 PROFILE -ER?

PROFILE -ER is a medical device that received FDA 510(k) clearance on 2003-11-10. The listed applicant is Medtox Diagnostics, Inc.. The 510(k) number is K033334.

When did PROFILE -ER receive FDA 510(k) clearance?

PROFILE -ER received FDA 510(k) clearance on 2003-11-10, under 510(k) number K033334.

Who is the listed applicant for PROFILE -ER?

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 PROFILE -ER?

The FDA product code for PROFILE -ER 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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