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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Cytomegalovirus
510(k) Number K951800
Device Name CMV IGG HUMAN SERUM CONTROLS
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 Number866.3175
Classification Product Code
GQI  
Date Received04/18/1995
Decision Date 11/16/1995
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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