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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
510(k) Number K880433
Device Name CYTOMEGALOVIRUS IGG EIA KIT
Applicant
De Ferris Laboratories, Inc.
26941 Cabot Rd., Suite 119
Laguna Hills,  CA  92653 -7006
Applicant Contact SMITH, PHD
Correspondent
De Ferris Laboratories, Inc.
26941 Cabot Rd., Suite 119
Laguna Hills,  CA  92653 -7006
Correspondent Contact SMITH, PHD
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received02/01/1988
Decision Date 03/27/1989
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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