FDA 510(k) Application Details - K962343

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii   More FDA Info for this Device
510(K) Number	K962343
Device Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant	GULL LABORATORIES, INC. 1011 MURRAY HOLLADAY RD. SALT LAKE CITY, UT 84117 US Other 510(k) Applications for this Company
Contact	FRED W RACHFORD, PH.D. Other 510(k) Applications for this Contact
Regulation Number	866.3780   More FDA Info for this Regulation Number
Classification Product Code	LGD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/1996
Decision Date	03/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review