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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, If, Toxoplasma Gondii
510(k) Number K850591
Device Name FIAX TOXO-M ANTIBODIES TEST KIT
Applicant
Intl. Diagnostic Technology
2050 Concourse Dr.
San Jose,  CA  95131
Applicant Contact DUFF SELF
Correspondent
Intl. Diagnostic Technology
2050 Concourse Dr.
San Jose,  CA  95131
Correspondent Contact DUFF SELF
Regulation Number866.3780
Classification Product Code
GLZ  
Date Received02/14/1985
Decision Date 04/30/1985
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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