FDA.reportPublic FDA data

AMS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14175191417519Amsino Healthcare (USA) Inc.1N2026-01-01330 CORPORATE WOODS PARKWAY Vernon Hills IL US 60061
20851751000160626AMSINO INTERNATIONAL, INC.1Y2026-01-01708 Corporate Center Dr POMONA CA US 91768
30055152113005515211AMSINO MEDICAL (SHANGHAI) CO., LTD.1N2026-01-01Building No. 1-3, 16, Lane 355, Huazhe Road Songjiang Export Processing Zone SHANGHAI CN 201613
30056698153005669815AMSINO MEDICAL (KUNSHAN) CO., LTD.1N2026-01-01582 SHIPU LIDU ROAD, QIANDENG TOWN KUNSHAN CITY Jiangsu CN 215343
30089898373008989837AMSEL MEDICAL CORPORATION1N2026-01-01705 Cambridge Street Cambridge MA US 02141
30149453843014945384AMSUSA LLC1Y2026-01-014025 Pleasantdale Rd Ste 540 Atlanta GA US 30340
30162486193016248619AMSINO MEDICAL INC.1Y2026-01-01700 Enterprise St. Aurora IL US 60504
30370012423037001242AMSINO SCIENTIFIC INC.1N2026-01-01124 Grove St, Suite 315 Franklin MA US 02038
10005004491000500449AMSCAN INC.1Y2020-04-2580 GRASSLANDS RD. ELMSFORD NY US 10523
30091285553009128555AMS DIAGNOSTICS1N2020-04-251790 N Commerce Pkwy Weston FL US 33326
30100626963010062696AMS Micromedical, LLC1N2020-04-25711 Spartan Drive Sparta WI US 54656

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1275621692504773K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SETLCP1999-12-21
1275621237339518K993481K-ASSAY C4DBI1999-11-29
1275621560875249K993437K-ASSAY C3CZW1999-11-24
1275621171779098K993323K-ASSAY IGMCFF1999-11-30
1275621818557333K993281K-ASSAY IGGDEW1999-11-09
1275621102861486K993213K-ASSAY IGACFF1999-11-23
1090411077296686K992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKEKNT2000-01-12
250071380778498K992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKEKNT2000-01-12
1275621447690227K972671BUN (LIQUID) REAGENT SETCDQ1997-07-20
1275621133550710K972155CREATINE KINASE (CK)CGS1997-07-17
1275621016006616K970560URIC ACID (LIQUID) REAGENT SETKNK1997-03-11
1275621875201175K961588TOTAL IRON (NITRO-PAPS) REAGENT SETJIY1996-11-18
1510511165677356K960110KIS MT3DZE1996-03-20
250071078513104K951528AMSINO DISPOSABLE VIGINAL SPECULUMHIB1995-05-11
1090411955967080K951528AMSINO DISPOSABLE VIGINAL SPECULUMHIB1995-05-11
1275621619554938K941315STANBIO Y-GT (LIQUICOLOR) TEST SETJQB1994-07-14
1275621030622120K941313STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SETCJE1994-05-17
1275622060040060K941287LIQUID ALT(SGPT) REAGENT SETCKA1994-05-03
1275621787768770K941132LIQUID AST (SGOT)REAGENT SETCIT1994-05-02
1275621982091401K921625CALCIUM-ARSENAZO III REAGENT SETCIC1992-05-13
1275621198549384K914873DIAZO COLORIMETRY, BILIRUBINCIG1991-12-04
1275621569563658K871781ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SETCFJ1987-06-03
1275621910391603K864882FERROZINE (COLORIMETRIC) IRON BINDING CAPACITYJIY1987-01-21
1275621355704879K862033TRIGLYCERIDESCDT1986-07-22
1275621761489838K853592MAGNESIUMJGJ1985-09-16
1275621316651064K832870DIAZO COLORIMETRY, BILLIRUBINCIG1983-09-26
1275621402183991K822471PSI ALBUMIN REAGENTCIX1982-09-14
1275621099012916K822470PSI INORGANIC PHOSPHORUSCEO1982-09-14
2242142068677479K820227STER-O-DOSECAF1982-02-23
1275621206940741K812794LIPASECET1981-10-20
1275621684628721K810673ENZYMATIC CHOLESTEROLCHH1981-03-31
250071642953274K220267AMSafe NeuFlo Needleless ConnectorFPA2022-10-07
250071132051444K213522AMSafe Pre-Filled Normal Saline Flush SyringeNGT2022-03-22
2242141810002884K201138AMSure® Single Use Saline Topical SolutionFRO2021-04-14
250071838174813K200051PUGGLE Enteral Feeding Pump and Feeding SetLZH2020-09-25
250071763366922K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGT2019-07-12
250071713717421K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterEZL2018-09-04
1090411654640570K181445AMSure Hydrophilic Intermittent CatheterEZD2018-10-01
250071088359756K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushFRO2018-09-07
250071769601589K173665AMSafe Sure-Lok Needle-Free ConnectorFPA2018-09-05
250072045617326K171857AMSure® Enteral Feeding Syringe with ENFit TipPNR2018-03-30
2237241022319677K163238Eclipse Kiss ZirconiaEIH2017-05-04
1510511552178388K160602JustRight Surgical Vessel Sealing SystemGEI2016-06-23
2077411395281092K140932AMSEL OCCLUDER DEVICEFZP2015-01-23
1275621778472243K131556DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SETJIT2013-06-26
1275621109696410K120763LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLSDJG2012-06-01
1275621592403676K120761LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLSDJG2012-05-08
1275621265703143K113661LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSLAF2012-01-23
1275621388071914K113139LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLSDIO2011-11-22
1275622073435727K113131LIASYS 450CFR2012-03-08
1275622045056526K110298OPIATE ENZYME IMMUNOASSAYDJG2011-07-15
1275621373405630K110239LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLLDJ2011-06-23
1510511271030374K102822IMPLANT-ONE SYSTEMDZE2011-01-10
1275621527371589K102210LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLSDKZ2010-12-28
250071145602924K101958AMSINO I.V. ADMINISTRATION AND EXTENSION SETSFPA2010-09-29
1090411891032598K101958AMSINO I.V. ADMINISTRATION AND EXTENSION SETSFPA2010-09-29
1090411392692868K101824AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETEREZL2010-09-13
1275621929701340K1011956-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLSDJG2010-07-06
1090411189972689K093773AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETSFPA2010-03-10
250071486245923K093773AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETSFPA2010-03-10
1090411304918356K091699AMSURE HYDROPHILIC LATEX FOLEY CATHETEREZL2009-08-10
250071661215981K091306AMSURE PVC INTERMITTENT CATHETEREZD2009-08-21
1275621681657686K090844BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLSDJG2009-07-30
2242141351403009K080779IRRISEPT WOUND CLEANSING SYSTEMFQH2009-02-04
1275621040325134K080468LIASYS WITH MODELS LIASYSCFR2008-07-25
1275621309963127K073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXMSJ2008-03-07
1275621990998425K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSLBR2008-01-22
1275621155923730K072395DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLSLBS2008-01-03
1275621019926472K071971DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CALLPS2007-09-17
250071198466040K070873AMSURE BLADDER IRRIGATION SETLJH2007-12-19
1275621987884084K070757MICROPROTEIN REAGENT SETJGP2007-12-04
250071041679117K070411AMSURE NEBULIZERCAF2007-10-01
1275621493828361K070251CARBON DIOXIDE LIQUID STABLE REAGENTKHS2007-04-30
1275621679958064K062105DIAZYME CREATININE LIQUID REAGENTS ASSAYJFY2007-04-23
250071021793739K061039AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLEFMF2006-06-29
1275621528881937K051088MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDKB2005-06-24
1090411216907108K051059AMSURE 100% SILICONE FOLEY CATHETEREZL2005-06-28
1275621516731951K050733OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLSDJG2005-06-13
250071165488156K050656AMSINO SUTURE REMOVAL KITMCZ2005-05-02
250071488696797K050654AMSINO I.V. START KITLRS2005-05-02
1275621609108793K033885BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)DIS2004-05-19
1275621756541054K033866CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)DIO2004-04-07
1275621636187577K033094ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)DKZ2003-12-19
1275621783444359K032764BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)DIS2003-11-03
1275621098529790K032461ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221DIC2003-10-03
1275621190031220K032365BENZODIAZEPINE ENZYME IMMUNOASSAYJXM2003-09-05
1275621661878068K031797METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)DJR2003-10-10
1275621219316888K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
250071423821899K030664AMSURE FOLEY INSERTION TRAYFCM2003-05-23
250071797763769K030293AMSURE RED RUBBER URETHRAL CATHETEREYB2004-02-04
1090411812852983K030293AMSURE RED RUBBER URETHRAL CATHETEREYB2004-02-04
1090411525473861K030120AMSURE FOLEY CATHETEREZL2003-10-29
1275621238903182K023860MICROALBUMIN REAGENT SET AND CALIBRATORSDDZ2003-04-28
1275621520478133K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)JXN2003-01-21
1275621698283567K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)CIJ2002-12-23
1275621098200335K023317METHADONE ENZYME IMMUNOASSAYDJR2002-12-12
1275621884734747K023316SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDLJ2002-12-16
250072055454753K023276AMSINO TRACHEOSTOMY CARE TRAYLRO2002-12-09
1275621500864050K021887CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071LDJ2002-08-15
1275621536407892K021449CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLSDLJ2002-06-18
3385001042061256K011587SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMPLZH2001-06-01
1275621757681167K002651C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SETDCK2000-10-13
1275621244445720K002199MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SETCFR2000-11-20
250071009929011
250071016517725
1090411017160852
250071027279552
250071040053072
250071057607629
250071131178771
250071148155036
250071159999376
1090411161741211
1090411171056510
1090411185903947
250071189688758
1090411215507452
250071223466527
1090411232960657
2369931234579956

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPA62022-10-07
DJG62012-06-01
EZL52018-09-04
CFR32012-03-08
NGT22022-03-22
FRO22021-04-14
LZH22020-09-25
EZD22018-10-01
DIO22011-11-22
LDJ22011-06-23
DZE22011-01-10
DKZ22010-12-28
CAF22007-10-01
DIS22004-05-19
EYB22004-02-04
DJR22003-10-10
LCP22003-08-06
DLJ22002-12-16
KNT22000-01-12
CFF21999-11-30
JIY21996-11-18
HIB21995-05-11
CIG21991-12-04
PNR12018-03-30
EIH12017-05-04
GEI12016-06-23
FZP12015-01-23
JIT12013-06-26
LAF12012-01-23
FQH12009-02-04
MSJ12008-03-07
LBR12008-01-22
LBS12008-01-03
LJH12007-12-19
JGP12007-12-04
LPS12007-09-17
KHS12007-04-30
JFY12007-04-23
FMF12006-06-29
DKB12005-06-24

NDC#

PMN#

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