FDA.reportPublic FDA data

Daniel Castellanos

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80439093002808498Daniel Castellanos1N2026-01-0177 4th Avenue Waltham MA US 02451

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
267101339435479P970037AUTODELFIA HAFP TEST KITLOK1998-03-31
267101210454487K950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEJJT1995-09-21
267101800764372K943547PHENYLALANINE TEST KITJNB1996-01-26
267101140160380K943416DELFIA NEONATAL THYROXINE KITCDX1995-03-10
267101296832193K905710PHARMACIA DELFIA NEONATAL HTSH KITJLW1991-02-21
267101192703321K862044DELFIA (TM) HCG KITJHJ1986-07-11
267101295155828K203035Eonis SCID-SMA kitPJI2022-11-09
267101977695420K193103NeoBase 2 Non-derivatized MSMS KitNQL2020-02-07
267101069722272K190335GSP Neonatal Total Galactose kitJIA2019-11-06
267101123103940K173829NeoLSD MSMS kitPQW2018-07-18
267101297540797K173568NeoBase 2 Non-derivatized MSMS KitNQL2018-09-04
267101436192024K133652GSP NEONATAL TOTAL GALACTOSE KITJIA2014-04-28
267101052438813K131284GSP NEONATAL BIOTINIDASE KITNAK2013-11-14
267101150990695K110274AUTODELFIA NEONATAL IRT KITJNO2011-06-10
267101878317409K103484GSP NEONATAL THYROXINE (T4)KLI2011-04-22
267101840951539K102419GSP NEONATAL IRT KIT (3306-001U)JNO2010-12-16
267101407466377K100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UJLX2010-07-23
267101595668912K100101GSP NEONATALGALT KIT, MODEL 3303-001UKQP2010-06-11
267101687078280K093916NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001UNQL2010-08-23
267101943115805K090846GSP INSTRUMENT AND GSP NEONATAL HTSH KITJLW2009-09-03
267101168603811K090123NEONATAL BIOTINIDASE KIT, MODEL 3018NAK2010-03-05
267101009376700K083130NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040NQL2009-07-09
267101312810336K081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITJLX2009-04-16
267101511283664K071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BJIA2008-08-07
267101122419745K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367GKA2006-03-08
267101744406211DEN200044Eonis SCID-SMA KitQUE2022-11-09
267101488506695DEN180056GSP Neonatal Creatine Kinase - MM kitQJE2019-12-12
267101664051046DEN140010PERKINELMER ENLITE NEONATAL TREC TEST SYSTEMPJI2014-12-15
267101327320765DEN040002NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970NQL2004-08-24
267101474380456
267101255984824
267101324043874
267101509635765
267101612781967
267101741164163
267101774678897
267101807514191
267101829243215
267101847246819
267101891821657
267101920125955
267101925114460
267102005253277
267102020634373
267102024579119

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NQL52020-02-07
JIA32019-11-06
PJI22022-11-09
NAK22013-11-14
JNO22011-06-10
JLX22010-07-23
JLW22009-09-03
QUE12022-11-09
QJE12019-12-12
PQW12018-07-18
KLI12011-04-22
KQP12010-06-11
GKA12006-03-08
LOK11998-03-31
JNB11996-01-26
JJT11995-09-21
CDX11995-03-10
JHJ11986-07-11