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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Agglutination Assay, Rubella
510(k) Number K954920
Device Name MUREX RUB-EX
Applicant
Murex Diagnostics, Inc.
3075 Northwoods Cir.
Norcross,  GA  30071
Applicant Contact ROBERT K SHOCKLEY
Correspondent
Murex Diagnostics, Inc.
3075 Northwoods Cir.
Norcross,  GA  30071
Correspondent Contact ROBERT K SHOCKLEY
Regulation Number866.3510
Classification Product Code
LQN  
Date Received10/26/1995
Decision Date 08/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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