Siemens Medical Solutions Diagnostics: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Siemens Medical Solutions Diagnostics” (first 2007, latest 2011), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 141 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 1 | 1 |
| MKW | Cyclosporine | 1 | 1 |
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | 1 | 1 |
| NQD | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
Review panels
- Immunology (5)
- Clinical Chemistry (3)
- Hematology (2)
- Clinical Toxicology (1)
Most recent Siemens Medical Solutions Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100910 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 | DHB | 2011-05-11 | 405 |
| K091984 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 | DHB | 2009-10-28 | 118 |
| K081895 | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS | LCP | 2009-01-08 | 189 |
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | MKW | 2008-09-11 | 475 |
| K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | MQM | 2008-06-27 | 193 |
| K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | DCN | 2008-04-01 | 194 |
| K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP | LTK | 2007-11-05 | 35 |
| K071466 | DCA VANTAGE, MODEL 5075 | LCP | 2007-10-09 | 133 |
| K072204 | ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS | JIX | 2007-10-05 | 58 |
| K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 | JFY | 2007-08-03 | 141 |
1 earlier clearances. See the full list in Caduvo.
Recalls
16 product recalls in 11 recall events; 0 initiated in the last five years. Most recent: 2015-03-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Siemens Medical Solutions USA, Inc. (784 510(k)s)
- Siemens Healthcare Diagnostics, Inc. (245 510(k)s)
- Siemens Corp. (67 510(k)s)
- Siemens Elema AB (63 510(k)s)
- Siemens Gammasonics, Inc. (53 510(k)s)
- Siemens Hearing Instruments, Inc. (42 510(k)s)
- Siemens Healthcare GmbH (32 510(k)s)
- Siemens Medi Cal Solutions, Inc. (32 510(k)s)
- Siemens AG Medical Solutions (31 510(k)s)
- Siemens Medical Systems, Inc. (25 510(k)s)
- Siemens Healthcare Diagnostics Products GmbH (23 510(k)s)
- Siemens AG (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Medical Solutions Diagnostics?
FDA lists 11 510(k) clearances under the applicant name “Siemens Medical Solutions Diagnostics” (first 2007, latest 2011), across 9 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Siemens Medical Solutions Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Medical Solutions Diagnostics is 141 days.
Which FDA product codes appear under Siemens Medical Solutions Diagnostics?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 2); LCP (Assay, Glycosylated Hemoglobin, 2); DCN (System, Test, C-Reactive Protein, 1).
Next steps
- See all 11 Siemens Medical Solutions Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code DHB, Siemens Medical Solutions Diagnostics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.