Siemens Healthcare Diagnostics
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories12
Latest FDA decision2025-10-17
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P030040 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2025-10-17 | View |
| PMA | P090024 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2025-10-17 | View |
| PMA | P990055 | ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) | NAF | 2025-07-16 | View |
| PMA | P950021 | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions | MTG | 2025-07-16 | View |
| PMA | P000021 | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | LTJ | 2025-05-22 | View |
| PMA | P020027 | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer | MTF | 2025-05-22 | View |
| 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 |
| PMA | P040004 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2022-03-29 | View |
| PMA | P030056 | Assay, enzyme linked immunosorbent, hepatitis c virus | MZO | 2021-04-27 | View |
| PMA | P030049 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2021-03-11 | 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 |
No matching devices.