FDA 510(k) Application Details - K220085

Device Classification Name	Tyrosine Phosphatase (Ia-2) Autoantibody Assay   More FDA Info for this Device
510(K) Number	K220085
Device Name	Tyrosine Phosphatase (Ia-2) Autoantibody Assay
Applicant	KRONUS, Inc. 170 S. Seneca Springs Way Suite 105 Star, ID 83669 US Other 510(k) Applications for this Company
Contact	Delaney Sauer Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	OIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2022
Decision Date	08/24/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review