Medical Device Manufacturer · US , New York , NY

Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices

152 submissions · 151 cleared · Since 2008
152
Total
151
Cleared
1
Denied
95 devices
76-95 of 95
Cleared Nov 30, 2012
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA...
K121994 · CDD
Chemistry · 147d
Cleared Oct 12, 2012
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
K122398 · JIX
Chemistry · 66d
Cleared Oct 03, 2012
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
K122599 · DDR
Chemistry · 37d
Cleared May 15, 2012
ADVIA CHEMISTRY GLUH_3 REAGENTS
K120681 · CFR
Chemistry · 70d
Cleared May 09, 2012
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
K121084 · JJX
Chemistry · 29d
Cleared Dec 30, 2011
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
K113373 · JIT
Chemistry · 44d
Cleared Oct 14, 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586 · MRG
Chemistry · 227d
Cleared Mar 18, 2011
EMIT II PLUS6-ACETYLMORPHINE ASSAY
K102779 · DJG
Chemistry · 175d
Cleared Feb 16, 2011
ENZYME II CALIBRATOR
K103836 · JIT
Chemistry · 48d
Cleared Jan 25, 2011
DIMENSION VISA ENZ 2 CAL
K103612 · JIX
Chemistry · 47d
Cleared May 22, 2009
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC...
K090330 · JFY
Chemistry · 101d
Cleared Mar 09, 2009
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
K083339 · CIC
Chemistry · 117d
Cleared Feb 26, 2009
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
K082638 · KLI
Chemistry · 169d
Cleared Feb 02, 2009
IMMULITE 2000 FREE T4
K083373 · CEC
Chemistry · 80d
Cleared Sep 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
K081789 · JIT
Chemistry · 77d
Cleared Aug 04, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319 · JIT
Chemistry · 84d
Cleared Jul 29, 2008
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP),...
K081294 · NQD
Chemistry · 83d
Cleared May 23, 2008
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF...
K081074 · JLW
Chemistry · 37d
Cleared May 23, 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103 · JIX
Chemistry · 35d
Cleared May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT...
K080578 · NBC
Chemistry · 74d

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