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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 K801667
Device Name GAMMA COAT(125 I) RUBELLA ANTIBODY
Applicant
Clinical Assays, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Clinical Assays, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3510
Classification Product Code
GOL  
Date Received07/21/1980
Decision Date 10/23/1980
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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