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510(k) Premarket Notification Database

Device Classification Name enzyme linked immunoabsorbent assay, toxoplasma gondii
510(k) NumberK903968
Device NameTOXO-CUBE
Applicant
DIFCO LABORATORIES, INC.
1180 ellsworth rd.
ann arbor,  MI  48104
Contactwalter fischer
Regulation Number866.3780
Classification Product Code
LGD
Date Received08/28/1990
Decision Date 12/18/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 02/06/2009

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