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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 K031834
Device Name XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
Applicant
Remel, Inc.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact EARLEEN C PARKS
Correspondent
Remel, Inc.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact EARLEEN C PARKS
Regulation Number866.3220
Classification Product Code
MHI  
Subsequent Product Code
MHJ  
Date Received06/13/2003
Decision Date 11/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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