DUOPATH VEROTOXINS GLISA TEST— 510(k) K031367

Name: FDA 510(k) clearance K031367
Creator: U.S. Food and Drug Administration
Published: 2004-01-23

Substantially Equivalent

Emd Chemicals, Inc.

FDA 510(k) clearance K031367 for DUOPATH VEROTOXINS GLISA TEST, Substantially Equivalent on 2004-01-23. Applicant: Emd Chemicals, Inc.. Device class: 1.

Clearance details

Applicant: Emd Chemicals, Inc.
Product code: Code GNA
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 2003-04-30
Decision date: 2004-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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