FDA 510(k) Application Details - K201440

Device Classification Name	System, Multipurpose For In Vitro Coagulation Studies   More FDA Info for this Device
510(K) Number	K201440
Device Name	System, Multipurpose For In Vitro Coagulation Studies
Applicant	Tem Innovations GmbH Martin-Kollar-Strasse 15 Munich 81829 DE Other 510(k) Applications for this Company
Contact	David Jacob 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	06/01/2020
Decision Date	07/08/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review