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FDA 510(k)

DUOPATH VEROTOXINS GLISA TEST

K-Number: K031367 · 2004-01-23

ApplicantEmd Chemicals, Inc.
Decision Date2004-01-23
Product CodeGNA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DUOPATH VEROTOXINS GLISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 2004-01-23 under 510(k) number K031367. The device is classified under product code GNA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUOPATH VEROTOXINS GLISA TEST?

DUOPATH VEROTOXINS GLISA TEST is a medical device that received FDA 510(k) clearance on 2004-01-23. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K031367.

When did DUOPATH VEROTOXINS GLISA TEST receive FDA 510(k) clearance?

DUOPATH VEROTOXINS GLISA TEST received FDA 510(k) clearance on 2004-01-23, under 510(k) number K031367.

Who is the listed applicant for DUOPATH VEROTOXINS GLISA TEST?

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

What is the FDA product code for DUOPATH VEROTOXINS GLISA TEST?

The FDA product code for DUOPATH VEROTOXINS GLISA TEST is GNA.

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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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