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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 K810309
Device Name RUBELLA ANTIBODIES TEST REAGENTS
Applicant
Calbiochem-Behring Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Calbiochem-Behring Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3510
Classification Product Code
GOL  
Date Received02/05/1981
Decision Date 03/11/1981
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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