Buhlmann Laboratories AG
SCHONENBUCH/BASEL Basel-Landschaft, CH
BUHLMANN LABORATORIES AG appears in FDA device records in SCHONENBUCH/BASEL Basel-Landschaft, CH. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Buhlmann Laboratories AG between 1995 and 2024. The busiest year on record is 2019, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | NXO | Substantially Equivalent | |
| K191718 | Buhlmann fCAL turbo and CALEX Cap | NXO | Substantially Equivalent | |
| K190784 | BUHLMANN fCAL turbo | NXO | Substantially Equivalent | |
| K181012 | BUHLMANN fCAL ELISA | NXO | Substantially Equivalent | |
| K954299 | BUHLMANN ANGIOSTENSIN II RIA | CIB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000191380 | 1000191380 | BUHLMANN LABORATORIES AG | BASELSTRASSE 55, SCHONENBUCH/BASEL Basel-Landschaft CH-4124 CH | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NXOCalprotectin, Fecal
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DAKComplement C1q, Antigen, Antiserum, Control
- NNIContainer, Specimen, Non-Sterile
- GIFDiluent, Blood Cell
- IGCFormalin-Saline
- PPMGeneral Purpose Reagent
- JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
- GGKProducts, Red-Cell Lysing Products
- KQNRadioassay, Angiotensin Converting Enzyme
- CIBRadioimmunoassay, Angiotensin I And Renin
- MVUReagents, Specific, Analyte
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain