Dade Chemistry Systems, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Dade Chemistry Systems, Inc.” (first 1996, latest 1997), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | 4 | 4 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 1 | 1 |
| JIW | Calibrator, Surrogate | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | 1 | 1 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 1 | 1 |
| MMI | Immunoassay Method, Troponin Subunit | 1 | 1 |
Review panels
- Clinical Chemistry (12)
- Immunology (1)
Most recent Dade Chemistry Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973650 | TROPONIN (TROP) METHOD | MMI | 1997-10-20 | 25 |
| K973100 | PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR | JIT | 1997-09-29 | 41 |
| K973099 | PROSTATE SPECIFIC ANTIGEN CONTROL | JJX | 1997-09-29 | 41 |
| K973101 | PROSTATE SPECIFIC ANTIGEN METHOD | LTJ | 1997-09-18 | 30 |
| K971141 | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM | CEC | 1997-04-28 | 31 |
| K970387 | HUMAN CHORIONIC GONADOTROPIN METHOD | DHA | 1997-03-10 | 35 |
| K970393 | THYROID STIMULATING HORMONE METHOD | JLW | 1997-03-03 | 28 |
| K970336 | MMB CALIBRATOR | JIT | 1997-03-03 | 33 |
| K970396 | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | JIW | 1997-02-20 | 17 |
| K970389 | THYROID CALIBRATOR | JIT | 1997-02-18 | 15 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dade Chemistry Systems, Inc..
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.
- Dade Behring, Inc. (343 510(k)s)
- Dade, Baxter Travenol Diagnostics, Inc. (44 510(k)s)
- Dade Microscan, Inc. (40 510(k)s)
- Dade Intl., Inc. (30 510(k)s)
- Dade Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dade Chemistry Systems, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Dade Chemistry Systems, Inc.” (first 1996, latest 1997), across 10 product codes in 2 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 Dade Chemistry Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dade Chemistry Systems, Inc. is 31 days.
Which FDA product codes appear under Dade Chemistry Systems, Inc.?
The most frequent FDA product codes under this applicant name are JIT (Calibrator, Secondary, 4); CEC (Radioimmunoassay, Free Thyroxine, 1); DHA (System, Test, Human Chorionic Gonadotropin, 1).
Next steps
- See all 13 Dade Chemistry Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIT, Dade Chemistry Systems, Inc.'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.