Calbiochem-Behring Corp.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Calbiochem-Behring Corp.” (first 1978, latest 1983), across 38 product codes in 5 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.
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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 2 | 2 |
| CDD | Radioassay, Vitamin B12 | 1 | 1 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 1 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 | 1 |
Plus 28 more product codes.
Review panels
- Clinical Chemistry (17)
- Immunology (14)
- Microbiology (7)
- Hematology (2)
- Pathology (1)
Most recent Calbiochem-Behring Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | JZQ | 1983-07-28 | 52 |
| K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY | LLL | 1983-04-27 | 27 |
| K830214 | AFT SYSTEM III | DHN | 1983-03-09 | 44 |
| K820812 | CREATINE KINASE-MB KIT | JHY | 1982-04-12 | 20 |
| K813493 | ENZYGNOST TM RUBELLA IGM | LFX | 1982-03-04 | 80 |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | DBL | 1982-01-26 | 13 |
| K812458 | PADAC | JTO | 1981-09-23 | 23 |
| K810718 | C-PEPTICE REAGENTS | JKD | 1981-03-31 | 14 |
| K810669 | PANTRAK E.K. | CIW | 1981-03-31 | 19 |
| K810404 | RHEUMATOID FACTORS REFERENCE SERUM | DHR | 1981-03-11 | 21 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Calbiochem-Behring Corp..
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.
- Calbiochem (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Calbiochem-Behring Corp.?
FDA lists 41 510(k) clearances under the applicant name “Calbiochem-Behring Corp.” (first 1978, latest 1983), across 38 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 Calbiochem-Behring Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Calbiochem-Behring Corp. is 31 days.
Which FDA product codes appear under Calbiochem-Behring Corp.?
The most frequent FDA product codes under this applicant name are DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); DHR (System, Test, Rheumatoid Factor, 2); GOL (Antigen, Ha (Including Ha Control), Rubella, 2).
Next steps
- See all 41 Calbiochem-Behring Corp. clearances with predicates and recalls
- Run predicate analysis for product code DHN, Calbiochem-Behring Corp.'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.