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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Giardia Spp.
510(k) Number K955157
Device Name PROSPECT GIARDIA/CRYPTOSPORIDIUM 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 Number866.3220
Classification Product Code
MHI  
Subsequent Product Code
MHJ  
Date Received11/13/1995
Decision Date 02/09/1996
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
Recalls CDRH Recalls
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