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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, Rubella
510(k) Number K903308
Device Name TRANSTAT-CMV(TM)
Applicant
Ab Sangtec Medical
3603-D Haven Ave.
Menlo Park,  CA  94025
Applicant Contact PHILIPPE POULETTY
Correspondent
Ab Sangtec Medical
3603-D Haven Ave.
Menlo Park,  CA  94025
Correspondent Contact PHILIPPE POULETTY
Regulation Number866.3510
Classification Product Code
LFX  
Date Received07/24/1990
Decision Date 12/04/1990
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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