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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 K863363
Device Name CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY
Applicant
Cytotech, Inc.
11035 Roselle St., Suite A
San Diego,  CA  92121
Applicant Contact KIEHL, PHD
Correspondent
Cytotech, Inc.
11035 Roselle St., Suite A
San Diego,  CA  92121
Correspondent Contact KIEHL, PHD
Regulation Number866.3780
Classification Product Code
LGD  
Date Received09/02/1986
Decision Date 11/13/1986
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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