Dade Behring, Inc.: FDA filings under this applicant name
FDA lists 343 510(k) clearances under the applicant name “Dade Behring, Inc.” (first 1978, latest 2010), plus 1 PMA decision, across 101 product codes in 5 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 37 | 37 |
| JIT | Calibrator, Secondary | 29 | 29 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 23 | 23 |
| JIX | Calibrator, Multi-Analyte Mixture | 18 | 18 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 12 | 12 |
| GKP | Instrument, Coagulation, Automated | 9 | 9 |
| DLJ | Calibrators, Drug Specific | 8 | 8 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 8 | 8 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 8 | 8 |
| MMI | Immunoassay Method, Troponin Subunit | 7 | 7 |
Plus 91 more product codes.
Review panels
- Clinical Chemistry (117)
- Microbiology (74)
- Clinical Toxicology (54)
- Immunology (52)
- Hematology (47)
Most recent Dade Behring, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | GGN | 2010-12-20 | 369 |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | CFN | 2008-07-28 | 95 |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | DEB | 2008-07-21 | 80 |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | DHX | 2008-06-25 | 379 |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | LOJ | 2008-06-04 | 358 |
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD | CEC | 2008-03-13 | 83 |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR | CFN | 2008-02-26 | 69 |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | JHM | 2008-02-21 | 113 |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | JFY | 2008-01-03 | 65 |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | DBA | 2007-12-21 | 60 |
333 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P920031 | PMA | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | 1996-10-02 |
Recalls
29 product recalls in 18 recall events; 0 initiated in the last five years. Most recent: 2008-09-30.
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 Behring, 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, Baxter Travenol Diagnostics, Inc. (44 510(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 Behring, Inc.?
FDA lists 343 510(k) clearances under the applicant name “Dade Behring, Inc.” (first 1978, latest 2010), plus 1 PMA decision, across 101 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 Behring, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dade Behring, Inc. is 56 days.
Which FDA product codes appear under Dade Behring, Inc.?
The most frequent FDA product codes under this applicant name are LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, 37); JIT (Calibrator, Secondary, 29); LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, 23).
Next steps
- See all 343 Dade Behring, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LON, Dade Behring, 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.