Siemens Healthcare Diagnostics Products GmbH
FDA 510(k) & PMA Approved Devices — 19 products
Total Devices19
Categories8
Latest Approval2024-10-10
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | QLU | 2024-10-10 | View |
| 510(k) | K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | CFN | 2023-12-13 | View |
| 510(k) | K220728 | vWF Ag | GGP | 2023-06-02 | View |
| 510(k) | K212559 | CardioPhase® hsCRP | NQD | 2022-12-16 | View |
| 510(k) | DEN200067 | INNOVANCE VWF Ac | QTY | 2022-09-29 | View |
| 510(k) | K212379 | N Latex FLC kappa, N Latex FLC lambda | DFH | 2022-03-02 | View |
| 510(k) | K201496 | N Latex FLC kappa, N Latex FLC lambda | DFH | 2021-10-29 | View |
| 510(k) | K193047 | N Latex FLC kappa, N Latex FLC lambda | DFH | 2021-07-14 | View |
| 510(k) | K190879 | N Latex FLC kappa, N Latex FLC lambda | DFH | 2019-05-03 | View |
| 510(k) | K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | DFH | 2018-11-01 | View |
| 510(k) | K181525 | INNOVANCE Free PS Ag | GGP | 2018-09-07 | View |
| 510(k) | K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | DFH | 2017-11-17 | View |
| 510(k) | K172333 | Sysmex CS-5100 | JPA | 2017-10-31 | View |
| 510(k) | K171072 | N Latex Cystatin C; N Protein Standard UY | NDY | 2017-05-12 | View |
| 510(k) | K162688 | Sysmex CS-2100i | JPA | 2016-12-26 | View |
| 510(k) | K162420 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | JPA | 2016-12-12 | View |
| 510(k) | K161317 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | JPA | 2016-09-02 | View |
| 510(k) | K161312 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | JPA | 2016-09-01 | View |
| 510(k) | K151259 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | JPA | 2016-01-26 | View |
No matching devices.