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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 K911444
Device Name RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM
Applicant
Wampole Laboratories
P.O. Box # 1
Cranbury,  NJ  08512
Applicant Contact KAREN VUKOBRATOVICH
Correspondent
Wampole Laboratories
P.O. Box # 1
Cranbury,  NJ  08512
Correspondent Contact KAREN VUKOBRATOVICH
Regulation Number866.3510
Classification Product Code
LFX  
Date Received04/01/1991
Decision Date 08/30/1991
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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