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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 K962028
Device Name WELLCOLEX E-COLI OI57 ZC60
Applicant
Murex Diagnostics, Inc.
3705 Northwoods Circle
Norcross,  GA  30071
Applicant Contact KEN SHOCKLEY, PH.D.
Correspondent
Murex Diagnostics, Inc.
3705 Northwoods Circle
Norcross,  GA  30071
Correspondent Contact KEN SHOCKLEY, PH.D.
Regulation Number866.3255
Classification Product Code
GNA  
Date Received05/23/1996
Decision Date 11/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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