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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Latex Agglutination, Cryptococcus Neoformans
510(k) Number K933997
Device Name PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
Applicant
Alexon Biomedical, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089 -1302
Applicant Contact SUSAN TURNER
Correspondent
Alexon Biomedical, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089 -1302
Correspondent Contact SUSAN TURNER
Regulation Number866.3165
Classification Product Code
GMD  
Date Received08/17/1993
Decision Date 11/22/1993
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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