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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 K922010
Device Name PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION
Applicant
Alexon, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact SUSAN TURNER
Correspondent
Alexon, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact SUSAN TURNER
Regulation Number866.3220
Classification Product Code
MHI  
Date Received04/30/1992
Decision Date 06/19/1992
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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