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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Staphylococcus Aureus
510(k) Number K945538
Device Name STAPHAUREX PLUS(TM)
Applicant
Murex Diagnostics Limitd
Central Rd., Temple Hill
Dartford, Kent Da1 5lr
England,  DE
Correspondent
Murex Diagnostics Limitd
Central Rd., Temple Hill
Dartford, Kent Da1 5lr
England,  DE
Regulation Number866.2660
Classification Product Code
JWX  
Date Received11/14/1994
Decision Date 06/01/1995
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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