Behring Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 145 510(k) clearances under the applicant name “Behring Diagnostics, Inc.” (first 1976, latest 1997), across 81 product codes in 5 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 7 | 7 |
| DHR | System, Test, Rheumatoid Factor | 5 | 5 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 5 | 5 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 5 | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 5 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 | 5 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 5 | 5 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 4 |
| JZW | Nephelometer | 4 | 4 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 3 |
Plus 71 more product codes.
Review panels
- Immunology (45)
- Hematology (37)
- Clinical Chemistry (36)
- Microbiology (19)
- Clinical Toxicology (7)
Most recent Behring Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973832 | OPUS HLH CONTROLS | JJX | 1997-10-27 | 20 |
| K972929 | N ANTISERUM TO HUMAN ALBUMIN | DCF | 1997-10-20 | 73 |
| K972840 | N ANTISERUM TO HUMAN TRANSFERRIN | DDG | 1997-10-17 | 77 |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | DBF | 1997-09-12 | 66 |
| K972316 | OPUS D-DIMER | GHH | 1997-09-09 | 81 |
| K972116 | VON WILLEBRAND REAGENT | GGP | 1997-07-25 | 50 |
| K972011 | OPUS ETHANOL | DIC | 1997-07-22 | 53 |
| K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) | DKB | 1997-06-25 | 55 |
| K971596 | EMIT II OPIATES 300/2000 ASSAY | DJG | 1997-06-25 | 55 |
| K964595 | OPUS PSA TEST SYSTEM | LTJ | 1997-06-24 | 218 |
135 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Behring 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 Behring Diagnostics, Inc. (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
Frequently asked questions
How many FDA 510(k) clearances are listed under Behring Diagnostics, Inc.?
FDA lists 145 510(k) clearances under the applicant name “Behring Diagnostics, Inc.” (first 1976, latest 1997), across 81 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 Behring Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Behring Diagnostics, Inc. is 70 days.
Which FDA product codes appear under Behring Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 7); DHR (System, Test, Rheumatoid Factor, 5); GGP (Test, Qualitative And Quantitative Factor Deficiency, 5).
Next steps
- See all 145 Behring Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Behring 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, 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.