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Siemens Healthcare Diagnostics Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30026376183002637618Siemens Healthcare Diagnostics Inc1N2026-01-01Point Of Care Headquarters 333 Coney St East Walpole MA US 02032

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
256971606389417K992257NEW MULTIPLES REAGENT STRIPSJIR1999-11-24
256971109109041K991315MICROALBUSTIX REAGENT STRIPS (OTC)JIR1999-11-12
256971365740856K984067STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAKJHX1999-01-13
256971798109729K984065STRATUS (R) CS MYOGLOBIN (MYO) TESTPAKDDR1998-12-14
256971475001911K981101STRATUS CS MYO CALPAKJIT1998-04-15
256971597051438K981099STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAKJHX1998-05-26
256971609345907K981098STRATUS CS CARDIAC TROPONIN I TESTPAKMMI1998-04-27
256971622628900K981097STRATUS CS CKMB CALPAKJIT1998-04-16
256971176381394K972706CLINITEK MICROALBUMIN REAGENT STRIPSCJG1997-09-09
256971165754689K970956CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5JJY1997-04-08
256971734462849K963142DCA 2000 + MICROALBUMIN/CREATININE ASSAYJIR1996-09-27
256971318885255K962021CIBA CORNING 348 SYSTEMCHL1996-06-24
256971762854442K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4GLK1996-07-26
256971511618689K960888CHEK-STIX U.T.I. SELF-TESTJMT1996-07-05
256971080154533K960546CLINITEK 50 URINE CHEMISTRY ANALYZERKQO1996-06-12
256971705449360K952516PRO-VENT, LINE DRAW, PULSATORJKA1995-07-14
256971142273818K951361DCA 2000 SYSTEM FOR HEMOGLOBIN A1CLCP1995-05-05
256971413781595K946206CIBA CORNING 8-- SERIES CO-OXIMETERCHL1995-01-30
256971233588325K943780NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)JJW1994-10-31
256971839799004K940971AMES DCA 2000 HEMOGLOBIN ALC CONTROLSLCP1994-07-19
256971061590157K935830CIBA CORNING 248 PH/BLOOD GAS ANALYZERCHL1994-02-03
256971141114639K934907860 MEASURMENT SYSTEMCHL1994-01-03
256971288949972K933373CIBA CORNING 300 SERIES SYSTEMJGS1993-08-19
256971409510141K932674CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEMKQO1993-08-19
256971174879070K931467CHEK-STIX CONTROL STRIPS FOR URINALYSISJJW1993-05-11
256971065870809K914619CVMJJY1991-11-22
256972010981708K911625AMES DCA 2000TM ANALYZER AND REAGENT SYSTEMLCP1991-09-05
256971839756206K905396HEMASTIX REAGENT STRIPSJIO1991-02-11
256972051504012K904188CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZERCHL1990-09-27
256971970111663K870036BAYER HEALTHCARE RAPIDQC PLUSJJS1987-01-14
256971391821562K830223FECAL OCCULT SLIDE TEST KITKHE1983-03-07
256971180455626K251543Atellica® IM TSH3-Ultra II (TSH3ULII)JLW2026-02-06
256971491542755K200509ADVIA Centaur Vitamin D Total (VitD)MRG2020-05-29
256972005167117K193493ADVIA Centaur Total IgE (tIgE)DGC2020-01-15
256971882790626K193489ADVIA Centaur BRMOI2020-02-13
256971305195764K193397ADVIA Centaur® Digoxin assayKXT2021-07-16
256971494663617K192788ADVIA Centaur Cortisol (COR)JFT2019-11-25
256971811300289K192240RAPIDPoint 500e Blood Gas SystemCHL2020-03-27
256971087124839K161964ADVIA Centaur HAV IgM AssayLOL2016-10-13
256971388480099K151964Xprecia Stride Coagulation System, Xprecia System PT ControlsGJS2016-09-30
256971825734105K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve MaterialJJX2015-07-17
256971163936204K142758ADVIA Centaur HAV total assayLOL2014-12-05
256971620959303K140717CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KITKQO2014-11-17
256972052757160K122539MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEMCHL2013-04-19
256971761301308K122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSJIX2012-10-12
256971059541268K113216RAPIDPOINT 500 BLOOD GAS ANALYERKHP2012-05-03
256971586579729K110303STRATUS CS ACUTE CARE D-DIMERDAP2011-05-16
256971988449404K110277RAPIDPOINT 405 NEONATAL BILIRUBINMQM2011-08-15
256971262657930K091216CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797JIL2009-10-09
256971114390619K073537NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265MQM2008-06-27
256971578500281K071834STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPMNBC2007-08-17
256971157819812K071466DCA VANTAGE, MODEL 5075LCP2007-10-09
256972069539100K063356STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAKDAP2007-03-23
256971568957124K063276CLINITEK ADVANTUS, MODEL 1420JIL2006-12-28
256972052006180K062924STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAKNQD2006-12-26
256971743884141K060548STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAKDHA2006-04-06
256971535643537K060369STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAKNQD2006-05-04
256971788864766K051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.JHX2005-09-08
256971936562864K051597STRATUS CS D-DIMERDAP2005-08-17
256971295724616K043228ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYSNBC2005-04-22
256971564583648K032563CLINITEST HCG PREGNANCY TESTJHI2003-12-23
256971355292236K031947BAYER CLINITEK STATUS ANALYZERKQO2003-12-19
256972051331348K031560BAYER RAPIDLAB 1200 SYSTEMCHL2003-12-17
256971712272945K022977STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-CDAP2002-11-27
256971544720357K021428CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEMJFY2002-07-05
256971475069107K020616BAYER RAPIDPOINT 405 SYSTEMGKR2002-07-17
256971875534380K012233STRATUS CS TROPONIN I CALIBRATORJIT2001-09-11
256971204910516K003696STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MODDHA2001-01-25
256971757905414K002738BAYER RAPIDPOINT 400 SYSTEMCHL2000-12-19
256971093446717
256971761396118
256971809451848
256971089575998
256971244158292
256971376055993
256971397141946
256971652896224
256971715108166
256971756909172
256971986954600
256971992262315

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CHL92020-03-27
KQO42014-11-17
DAP42011-05-16
LCP42007-10-09
JHX32005-09-08
JIT32001-09-11
JIR31999-11-24
LOL22016-10-13
MQM22011-08-15
JIL22009-10-09
NBC22007-08-17
NQD22006-12-26
DHA22006-04-06
JJY21997-04-08
JJW21994-10-31
JLW12026-02-06
KXT12021-07-16
MRG12020-05-29
MOI12020-02-13
DGC12020-01-15
JFT12019-11-25
GJS12016-09-30
JJX12015-07-17
JIX12012-10-12
KHP12012-05-03
JHI12003-12-23
GKR12002-07-17
JFY12002-07-05
DDR11998-12-14
MMI11998-04-27
CJG11997-09-09
GLK11996-07-26
JMT11996-07-05
JKA11995-07-14
JGS11993-08-19
JIO11991-02-11
JJS11987-01-14
KHE11983-03-07

PMN#