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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 K031942
Device Name XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
Applicant
Remel, Inc.
1400 Unity St. Northwest
Ramsey,  MN  55303
Applicant Contact RICHARD TYSON
Correspondent
Remel, Inc.
1400 Unity St. Northwest
Ramsey,  MN  55303
Correspondent Contact RICHARD TYSON
Regulation Number866.3220
Classification Product Code
MHI  
Date Received06/24/2003
Decision Date 11/18/2003
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
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