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FDA 510(k)

PROFILE II ER

K-Number: K010138 · 2001-02-14

ApplicantMedtox Diagnostics, Inc.
Decision Date2001-02-14
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PROFILE II 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 2001-02-14 under 510(k) number K010138. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFILE II ER?

PROFILE II ER is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Medtox Diagnostics, Inc.. The 510(k) number is K010138.

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

PROFILE II ER received FDA 510(k) clearance on 2001-02-14, under 510(k) number K010138.

Who is the listed applicant for PROFILE II 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 II ER?

The FDA product code for PROFILE II ER is LDJ.

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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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