FDA.report

Terumo BCT, Inc..

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
17220281000117351Terumo BCT, Inc..1Y2026-01-0110811 W COLLINS AVE Lakewood CO US 80215

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
125551567601058K991430SMARTPREP CENTRIFUGE SYSTEMJQC1999-05-28
125551767730244K900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICLKN1991-03-22
125551585209618K893962COBE 2991 SUPPLEMENTARY DISPOSABLE SETSLKN1989-10-18
125551415199556K854446TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SETFPA1986-01-09
125551389045681K831004AUTOMATED 8400 BLOOD CELL SEPARATORLKN1983-09-12
125551913810067K801082GAMBRO HEMOFREEZE-BAGKSR1980-10-31
125551249052046K790105TERUMO IMUGARDGKT1979-05-24
125551996515740K760856BLOOD CELL PROCESSOR MODEL 2 IBM 2991GKT1977-01-10
125551618849389K183081Spectra Optia Apheresis SystemLKN2019-02-05
125551638134027K181049Spectra Optia Apheresis SystemLKN2018-11-01
125551230838807K172590Spectra Optia Apheresis SystemLKN2018-03-02
125551762633553K162365T-CuffKCY2017-02-16
125551520557812K153601Spectra Optia Apheresis SystemLKN2016-01-14
125551719823293K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection AdapterLKN2015-09-11
125551839836145K141938SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)LKN2015-03-23
125551213832341K132429SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SETLKN2013-12-06
125551276705428K131744SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARELKN2013-08-08
125551877428486K121005ADIPREP ADIPOSE TRANSFER SYSTEMMUU2012-09-21
125551228788659K113480SPECTRA OPTIA APHERESIS SYSTEMLKN2012-01-20
125551507316340K103340SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEMJQC2010-12-06
125551209712297K103090SPECTRA OPTIA R APHERESIS SYSTEMLKN2010-11-19
125551667974423K071079SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200LKN2007-08-02
125551601310708K052925SMARTPREP2 CENTRIFUGE SYSTEMJQC2006-01-04
125551615657613K043261HARVEST GRAFT DELIVERY SYRINGEFMF2005-03-11
125551587079535K020252SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2FMF2002-04-05
125551571674485K011032SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULALYC2001-07-03
125551820441103K000456HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2FMF2000-06-01
125551556981028BK990025
125551423434563BK980004
125551311103216BK970023
125551815551372BK970005
125551254209736BK960076
125551154449915BK950065
125551098077301BK950058
125551034081836BK950056
125551219276075BK950039
125551144512690BK950030
125551963383125BK950024
125551383810460BK940016
125551970177182BK930017
125551511826733BK920040
125551303291892BK920036
125551517484695BK920011
125551752029240BK910020
125551784563904BK900028
125551129734200BK900004
125551337638548BK900003
125551767312148BK900002
125551102179866BK890032
125551234368026BK890017
125551954604937BK870022
125551057353281BK860041
125552001555216BK860012
125551811156752BK830020
125551904341531BK830003
125551087463005BK820001
125551246771335BK241097
125551429858941BK231035
125552040345906BK230843
125551538925185BK230838
125551926039942BK210658
125552000630476BK210635
125552005988750BK190333
125551199319490BK190332
125551947561170BK180258
125551822870945BK180231
125551549806185BK170157
125551079567077BK170098
125551647646887BK170059
125551864246354BK160116
125551647799861BK160108
125551148348147BK150321
125551490036381BK150269
125551162450588BK150251
125551843427490BK150228
125551729790373BK140191
125552038592207BK140180
125551667243363BK140158
125551064990121BK140151
125551561057514BK140104
125551964379627BK130080
125551064483345BK130068
125551610722996BK130065
125551263482794BK130031
125551572541673BK120076
125551743837827BK120049
125551712698584BK120040
125551071532591BK120038
125551279159046BK120017
125551809690017BK120012
125551615730895BK110071
125551073074813BK110068
125551882512365BK110051
125551630224667BK110009
125551846353021BK100059
125552040040632BK100032
125551388321738BK090003
125551016209365BK080058
125551565114274BK080043
125551247403100BK080035
125551155857558BK080029
125551752342036BK080010
125551610855942BK070066
125551207686424BK070018
125551944544775BK070001
125551134178517BK040086
125551794507685BK040069
125551454734667BK030083
125552027271345BK030021
125551969042077BK020041
125551384367498BK020015
125551978017433BK010050
125551794268054BK010046
125551967743528BK010037
125551757659637BK010006
125551789923607BK000037
125551137091923
125551085836624
125551757845369

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LKN142019-02-05
JQC32010-12-06
FMF32005-03-11
GKT21979-05-24
KCY12017-02-16
MUU12012-09-21
LYC12001-07-03
FPA11986-01-09
KSR11980-10-31

PMN