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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 K780885
Device Name CORDIA R
Applicant
Cordis Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Cordis Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3510
Classification Product Code
GOL  
Date Received05/26/1978
Decision Date 01/17/1979
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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