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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 K020583
Device Name IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
Applicant
Ivd Research, Inc.
5909 Sea Lion Pl., Suite D
Carlsbad,  CA  92008
Applicant Contact DAVE LAMBILLOTTE
Correspondent
Ivd Research, Inc.
5909 Sea Lion Pl., Suite D
Carlsbad,  CA  92008
Correspondent Contact DAVE LAMBILLOTTE
Regulation Number866.3220
Classification Product Code
MHI  
Date Received02/21/2002
Decision Date 09/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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