FDA 510(k) Application Details - K210596

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii   More FDA Info for this Device
510(K) Number	K210596
Device Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant	Abbott Laboratories Dept 09AA, Bldg. Ap8-1, 100 Abbott Park Rd. Abbott Park, IL 60064 US Other 510(k) Applications for this Company
Contact	Linda Sohn 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	03/01/2021
Decision Date	05/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review