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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubella
510(k) Number K861282
Device Name MUREX SUDS RUBELLA
Applicant
Murex Corp.
P.O. Noc 2003
Norcross,  GA  30091
Applicant Contact MARSHALL, PH.D
Correspondent
Murex Corp.
P.O. Noc 2003
Norcross,  GA  30091
Correspondent Contact MARSHALL, PH.D
Regulation Number866.3510
Classification Product Code
LFX  
Date Received04/07/1986
Decision Date 06/13/1986
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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