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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 K875258
Device Name TOXOPLASMA GONDII IGG ELISA KIT
Applicant
De Ferris Laboratories, Inc.
6311 De Soto Ave.
Suite F
Woodland Hills,  CA  91367
Applicant Contact SMITH, PHD
Correspondent
De Ferris Laboratories, Inc.
6311 De Soto Ave.
Suite F
Woodland Hills,  CA  91367
Correspondent Contact SMITH, PHD
Regulation Number866.3780
Classification Product Code
LGD  
Date Received12/22/1987
Decision Date 09/30/1988
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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