NDS — Media, Culture, Ex Vivo, Tissue And Cell Class II

FDA Device Classification

Classification Details

Product Code
NDS
Device Class
Class II
Regulation Number
876.5885
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232543yocon biology technologyMSC SFMSeptember 6, 2024
K240247duogenic stemcells corporation“MoFi” Cell Culture Basal MediumJuly 12, 2024
K231804fujifilm irvine scientificPRIME-XV FreezIS DMSO-Free MDNovember 9, 2023
K201789energy delivery solutionsCT-STORSeptember 20, 2021
K113566life technologiesOPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUMJune 21, 2012
K103302life technologies corporationSTEMPRO MSC SFMFebruary 18, 2011
K100616life technologies corporationKNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618May 20, 2010
K022086invitrogen corporationAIM-V (R) MEDIUM, MODEL 087-0112December 23, 2002
DEN000008life technologiesDULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)February 16, 2001