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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 K900818
Device Name VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.
Applicant
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Applicant Contact CAROL K GRAVENS
Correspondent
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Correspondent Contact CAROL K GRAVENS
Regulation Number866.3780
Classification Product Code
LGD  
Date Received02/21/1990
Decision Date 04/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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