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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 K922737
Device Name VIDAS TOXO IG6 ASSAY (TX6)
Applicant
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042
Applicant Contact CHERYL WINTERS-HEARD
Correspondent
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042
Correspondent Contact CHERYL WINTERS-HEARD
Regulation Number866.3780
Classification Product Code
LGD  
Date Received06/08/1992
Decision Date 05/11/1993
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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