FDA 510(k) Application Details - K201570

Device Classification Name	Platelet Factor 4 Radioimmunoassay   More FDA Info for this Device
510(K) Number	K201570
Device Name	Platelet Factor 4 Radioimmunoassay
Applicant	Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha, WI 53186 US Other 510(k) Applications for this Company
Contact	Allison Stray Other 510(k) Applications for this Contact
Regulation Number	864.7695   More FDA Info for this Regulation Number
Classification Product Code	LCO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2020
Decision Date	09/11/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review