Siemens Healthcare Diagnostics - FDA 510(k) Cleared Devices

Cleared Apr 07, 2011

DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

K110169 · JIT

Chemistry · 77d

Cleared Mar 07, 2011

ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429

K101854 · CFR

Chemistry · 249d

Cleared Nov 23, 2010

ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL

K102904 · JJX

Chemistry · 53d

Cleared Jul 09, 2010

LOCI 8 CALIBRATOR, MODEL KC 646

K101460 · JIX

Chemistry · 44d

Cleared May 19, 2010

ADVIA CHEMISTRY SALICYLATE REAGENT

K093939 · DKJ

Chemistry · 148d

Cleared May 10, 2010

ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF...

K100289 · KHS

Chemistry · 97d

Cleared May 05, 2010

DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A

K100778 · JIX

Chemistry · 47d

Cleared Apr 07, 2010

DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435

K093441 · KXT

Chemistry · 153d

Cleared Mar 22, 2010

ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770

K093732 · JIX

Chemistry · 108d

Cleared Mar 05, 2010

EXL ANEM CAL, MODEL RC640

K093645 · JIX

Chemistry · 100d

Cleared Feb 12, 2010

B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644

K093631 · CDD

Chemistry · 80d

Cleared Jan 14, 2010

ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE...

K091867 · CDZ

Chemistry · 205d

Cleared Nov 20, 2009

ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL

K092993 · JJX

Chemistry · 53d

Cleared Oct 09, 2009

CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797

K091216 · JIL

Chemistry · 165d

Cleared Aug 14, 2009

ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS

K091123 · JJX

Chemistry · 119d

Cleared May 08, 2009

ADVIA CENTAUR TSH3-ULTRA METHOD

K083844 · JLW

Chemistry · 135d

Cleared Apr 02, 2009

ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL),...

K083386 · CJY

Chemistry · 136d

Cleared Mar 11, 2009

ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR,...

K083906 · NDY

Chemistry · 71d

Cleared Feb 27, 2009

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

K083462 · JIT

Chemistry · 95d

Cleared Feb 27, 2009

DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA...

K083465 · CGS

Chemistry · 95d

Cleared Feb 20, 2009

DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360

K083579 · JIX

Chemistry · 78d

Cleared Dec 10, 2008

DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE,...

K071474 · NTV

Chemistry · 561d

Cleared Oct 10, 2008

LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623

K082680 · JIT

Chemistry · 25d

Cleared Sep 22, 2008

DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT...

K082645 · NBC

Chemistry · 11d

Cleared Aug 29, 2008

DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE,...

K081731 · CGS

Chemistry · 71d