FDA 510(k) Application Details - K213690

Device Classification Name	Tubes, Vials, Systems, Serum Separators, Blood Collection   More FDA Info for this Device
510(K) Number	K213690
Device Name	Tubes, Vials, Systems, Serum Separators, Blood Collection
Applicant	Eclipse Medcorp LLC 5916 Stone Creek Drive Suite #120 The Colony, TX 75056 US Other 510(k) Applications for this Company
Contact	Julie Summerville Other 510(k) Applications for this Contact
Regulation Number	862.1675   More FDA Info for this Regulation Number
Classification Product Code	JKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2021
Decision Date	10/26/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review