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FDA 510(k)

PROFILE-II MODEL 600582

K-Number: K982211 · 1998-07-29

ApplicantMedtox Diagnostics, Inc.
Decision Date1998-07-29
Product CodeDKE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PROFILE-II MODEL 600582 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 1998-07-29 under 510(k) number K982211. The device is classified under product code DKE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFILE-II MODEL 600582?

PROFILE-II MODEL 600582 is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Medtox Diagnostics, Inc.. The 510(k) number is K982211.

When did PROFILE-II MODEL 600582 receive FDA 510(k) clearance?

PROFILE-II MODEL 600582 received FDA 510(k) clearance on 1998-07-29, under 510(k) number K982211.

Who is the listed applicant for PROFILE-II MODEL 600582?

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 MODEL 600582?

The FDA product code for PROFILE-II MODEL 600582 is DKE.

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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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