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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Ha (Including Ha Control), Rubella
510(k) Number K760889
Device Name TEST FOR DETECTION OF ANTIRUBELLA ANTIB
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number866.3510
Classification Product Code
GOL  
Date Received10/26/1976
Decision Date 11/16/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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