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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Types, Escherichia Coli
510(k) Number K031367
Device Name DUOPATH VEROTOXINS GLISA TEST
Applicant
Emd Chemicals, Inc.
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact ANNA G BENTLEY
Correspondent
Emd Chemicals, Inc.
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact ANNA G BENTLEY
Regulation Number866.3255
Classification Product Code
GNA  
Date Received04/30/2003
Decision Date 01/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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