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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
510(k) Number K013839
Device Name BIO-RAD PLATELIA TOXO IGG TMB
Applicant
Bio-Rad
6565 185th Ave., NE
Redmond,  WA  98052
Applicant Contact CHRISTOPHER BENTSEN
Correspondent
Bio-Rad
6565 185th Ave., NE
Redmond,  WA  98052
Correspondent Contact CHRISTOPHER BENTSEN
Regulation Number866.3780
Classification Product Code
LGD  
Date Received11/19/2001
Decision Date 09/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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