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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Rubella
510(k) Number K953826
Device Name ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA
Applicant
Pyramid Biological Corp.
6454 Van Nuys Blvd., Suite 111
Van Nuys,  CA  91401
Applicant Contact JEANETTE R PORRETTA
Correspondent
Pyramid Biological Corp.
6454 Van Nuys Blvd., Suite 111
Van Nuys,  CA  91401
Correspondent Contact JEANETTE R PORRETTA
Regulation Number866.3510
Classification Product Code
GOM  
Date Received08/15/1995
Decision Date 12/14/1995
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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