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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 K090847
Device Name PLATELIA TOXO IGM KIT MODEL 26211
Applicant
Bio-Rad Laboratories
6565 185th Ave., NE
Redmond,  WA  98052
Applicant Contact PRIYA BONDRE
Correspondent
Bio-Rad Laboratories
6565 185th Ave., NE
Redmond,  WA  98052
Correspondent Contact PRIYA BONDRE
Regulation Number866.3780
Classification Product Code
LGD  
Date Received03/30/2009
Decision Date 07/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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