FDA.reportPublic FDA data

FUJIFILM Biosciences INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20223792022379FUJIFILM Biosciences INC.1N2026-01-012511 DAIMLER ST Santa Ana CA US 92705

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
342141674717952K991420MODIFIED HAM'S F-10 WITH ALBUMINMQL1999-07-02
342141381768013K991419MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILIMQL1999-09-14
342141933796193K991339TYRODE'S SOLUTION-ACIDIFIEDMQL1999-12-06
342141680123444K991338BOVINE SERUM ALBUMIN (BSA)MQL1999-07-14
342141993457044K991337SPERM MAINTENANCE MEDIUM WITH GLYCEROLMQL1999-07-08
342141373713263K983589P-1 (PREIMPLANTATION STAGE ONE) MEDIUMMQL1999-02-18
342141991774572K983580BLASTOCYST MEDIUMMQL1999-02-18
342141141108578K983579SYNTHETIC SERUM SUBSTITUTE (SSS)MQL1999-04-23
342142053157771K122982CRYOLOCKMQK2014-01-09
342141352037048K093273VIT KIT - FREEZE AND THAWMQL2010-03-03
342141633984838K092554BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTESMQH2010-04-30
342141235542676K092398HSV STRAWMQK2010-10-06
342141574731801K072600INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTESMQH2008-05-19
342141103122864K063304LIFE4CLYX2007-12-21
342141380047567K060168VITRIFICATION FREEZE KIT, VITRIFICATION THAW KITMQL2006-04-24
342141257645893K041562CRYOTIPMQH2004-08-09
342142069909141K034063MULTIBLAST MEDIUMMQL2004-04-26
342141644710859K033462EARLY CLEAVAGE MEDIUM (ECM)MQL2004-01-15
342142015827076K021358EMBRYO BIOPSY MEDIUMMQL2002-07-05
342141611682509K013518EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUMMQL2002-01-18
342141474292483K011598WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USEMTW2001-06-13
342141441783763K003448DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301MQL2000-12-07
342141930710509K002595CBS STRAWMQG2000-11-17
342141792862053K000309BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUMMQL2000-03-13
342141021937773
342141031707691
342141068162009
342141101015693
342141321520494
342141444781739
342141488440198
342141527973408
342141529661586
342141570671785
342141644537701
342141742039282
342141777988237
342141799864243
342141895234294
342141911614847
342141946608076
342141971783103
342142000210256
342142024774772
342142051078537
342142059144041

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQL162010-03-03
MQH32010-04-30
MQK22014-01-09
LYX12007-12-21
MTW12001-06-13
MQG12000-11-17