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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cryptosporidium Spp.
510(k) Number K936191
Device Name PROSPECT CRYPTOSPORIDIUM RAPID ASSAY
Applicant
Alexon Biomedical, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089
Applicant Contact SUSAN TURNER, PH.D
Correspondent
Alexon Biomedical, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089
Correspondent Contact SUSAN TURNER, PH.D
Regulation Number866.3220
Classification Product Code
MHJ  
Date Received12/23/1993
Decision Date 11/17/1994
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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