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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 K902792
Device Name TOXOPLASMA GONDII IGG
Applicant
Pharmacia Diagnostics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Applicant Contact KAREN DARCY
Correspondent
Pharmacia Diagnostics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact KAREN DARCY
Regulation Number866.3780
Classification Product Code
LGD  
Date Received06/26/1990
Decision Date 07/24/1990
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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