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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
Recalls CDRH Recalls
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