Siemens Healthcare Diagnostics
FDA 510(k) & PMA Approved Devices — 85 products
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Total Devices85
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | JLW | 2025-04-25 | View |
| 510(k) | K162977 | ADVIA 2120i, ADVIA 2120 | GKZ | 2017-08-11 | View |
| 510(k) | K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | MRG | 2017-03-16 | View |
| 510(k) | K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) | JGS | 2017-03-09 | View |
| 510(k) | K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | JIT | 2016-11-17 | View |
| 510(k) | K151964 | Xprecia Stride Coagulation System, Xprecia System PT Controls | GJS | 2016-09-30 | View |
| 510(k) | K122539 | MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM | CHL | 2013-04-19 | View |
| 510(k) | K130698 | DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) | JIT | 2013-04-05 | View |
| 510(k) | K121981 | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY | CEW | 2013-03-21 | View |
| 510(k) | K123677 | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) | JIF | 2013-03-07 | View |
| 510(k) | K123321 | DIMENSION CHEMISTRY III CALIBRATORY | JIX | 2013-02-15 | View |
| 510(k) | K123320 | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE | JIF | 2013-02-15 | View |
| 510(k) | K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI | CJO | 2012-08-28 | View |
| 510(k) | K121907 | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR | CJO | 2012-07-23 | View |
| 510(k) | K113216 | RAPIDPOINT 500 BLOOD GAS ANALYER | KHP | 2012-05-03 | View |
| 510(k) | K102644 | ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I | GKZ | 2011-11-23 | View |
| 510(k) | K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM | JJE | 2011-11-22 | View |
| 510(k) | K112142 | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE | NDW | 2011-11-04 | View |
| 510(k) | K110061 | CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL | JJX | 2011-09-21 | View |
| 510(k) | K110934 | ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY | LCP | 2011-08-25 | View |
No matching devices.
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