FDA 510(k) Application Details - K173704

Device Classification Name	More FDA Info for this Device
510(K) Number	K173704
Device Name	ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
Applicant	Phadia AB Rapsgatan 7P Uppsala 75137 SE Other 510(k) Applications for this Company
Contact	Carina Magnusson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2017
Decision Date	03/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review