Dade, Baxter Travenol Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Dade, Baxter Travenol Diagnostics, Inc.” (first 1976, latest 1980), across 34 product codes in 5 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | 4 | 4 |
| JPK | Mixture, Hematology Quality Control | 3 | 3 |
| GJW | Pipette, Pasteur | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | 2 |
| KHQ | Radioassay, Triiodothyronine Uptake | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DDX | Plasminogen, Antigen, Antiserum, Control | 1 | 1 |
Plus 24 more product codes.
Review panels
- Hematology (22)
- Clinical Chemistry (16)
- Immunology (2)
- Pathology (1)
- Clinical Toxicology (1)
Most recent Dade, Baxter Travenol Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | GGM | 1980-03-05 | 23 |
| K792606 | WHOLE BLOOD PLATELET CONTROL NORMAL, | JPK | 1980-02-13 | 57 |
| K792723 | BLOOD FLUID FILTERS | JKA | 1980-01-21 | 21 |
| K792607 | T3 UPTAKE (T3U) REAGENTS | KHQ | 1980-01-16 | 29 |
| K792443 | TSH RADIOIMMUNOASSAY | JLW | 1979-12-27 | 28 |
| K792442 | FERRITIN RADIOIMMUNOASSAY | DBF | 1979-12-18 | 19 |
| K791922 | HARLECO BRAND CLINICARD LIPASE TEST SET | CET | 1979-11-27 | 62 |
| K792183 | DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO | LBS | 1979-11-13 | 15 |
| K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) | KSG | 1979-05-23 | 33 |
| K790767 | IMMU-TEK AUTOMATIC CENTRIFUGE | KSN | 1979-05-23 | 34 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dade, Baxter Travenol Diagnostics, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Dade, Baxter Travenol Diagnostics, Inc. (a text match, not an official crosswalk):
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 Microscan, Inc. (40 510(k)s)
- Dade Intl., Inc. (30 510(k)s)
- Dade Chemistry Systems, Inc. (13 510(k)s)
- Dade Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dade, Baxter Travenol Diagnostics, Inc.?
FDA lists 44 510(k) clearances under the applicant name “Dade, Baxter Travenol Diagnostics, Inc.” (first 1976, latest 1980), across 34 product codes in 5 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, Baxter Travenol Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dade, Baxter Travenol Diagnostics, Inc. is 34 days.
Which FDA product codes appear under Dade, Baxter Travenol Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JJT (Enzyme Controls (Assayed And Unassayed), 4); JPK (Mixture, Hematology Quality Control, 3); GJW (Pipette, Pasteur, 2).
Next steps
- See all 44 Dade, Baxter Travenol Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJT, Dade, Baxter Travenol Diagnostics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.