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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 K915093
Device Name PROSPECT(TM) GIARDIA RAPID ASSAY
Applicant
Alexon, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact TERRI A MARELLO
Correspondent
Alexon, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact TERRI A MARELLO
Regulation Number866.3220
Classification Product Code
MHI  
Date Received11/12/1991
Decision Date 01/30/1992
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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