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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Control), Rubella
510(k) Number K894262
Device Name RUBELLA ANTIGEN AND CONTROL ANTIGEN
Applicant
Microbix Biosystems, Inc.
Darts Mill
Flemington,  NJ  08822
Applicant Contact JANIS FREESTONE
Correspondent
Microbix Biosystems, Inc.
Darts Mill
Flemington,  NJ  08822
Correspondent Contact JANIS FREESTONE
Regulation Number866.3510
Classification Product Code
GON  
Date Received06/21/1989
Decision Date 10/16/1989
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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