FDA 510(k) Application Details - K243858

Device Classification Name	System, Multipurpose For In Vitro Coagulation Studies   More FDA Info for this Device
510(K) Number	K243858
Device Name	System, Multipurpose For In Vitro Coagulation Studies
Applicant	Haemonetics Corporation 125 Summer Street Boston, MA 02110 US Other 510(k) Applications for this Company
Contact	Erica Molaro Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	JPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2024
Decision Date	01/15/2025
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