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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 K930451
Device Name PROSPEC T GIARDIA MICROTITER ASSAY
Applicant
Alexon, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089
Applicant Contact SUSAN TURNER
Correspondent
Alexon, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089
Correspondent Contact SUSAN TURNER
Regulation Number866.3220
Classification Product Code
MHI  
Date Received01/27/1993
Decision Date 04/21/1993
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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