Data / Medical devices / Switzerland / Buhlmann Laboratories AG
Buhlmann Laboratories AG: FDA-registered device maker in SCHONENBUCH/BASEL Basel-Landschaft, Switzerland, 6 510(k) clearances
Buhlmann Laboratories AG is registered with the FDA (registration 1000191380) in SCHONENBUCH/BASEL Basel-Landschaft, Switzerland. It lists 11 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000191380
- Address
- Baselstrasse 55, SCHONENBUCH/BASEL Basel-Landschaft, Switzerland, CH-4124
- Owner or operator
- BUHLMANN LABORATORIES AG (9023594)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 7, 2007
- Registered through
- 2026
- Brand names listed
- BUHLMANN fCAL® ELISA (fecal calprotectin), BUHLMANN fCAL® turbo (fecal calprotectin turbidimetric assay), BUHLMANN fCAL® turbo (fecal calprotectin turbidimetric assay), CALEX® Cap (stool preparation device), BUHLMANN fPELA® turbo (fecal pancreatic elastase turbidimetric assay), Buhlmann ACE Kinetic Assay, Buhlmann CIC-C1q EIA, CALEX® Cap, CAST® Lysing Reagent Basophil and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calprotectin, Fecal | NXO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Manufacturer | accessdata.fda.gov |
| Complement C1q, Antigen, Antiserum, Control | DAK | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Diluent, Blood Cell | GIF | 1 | Manufacturer | accessdata.fda.gov |
| Formalin-Saline | IGC | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | JNN | 1 | Manufacturer | accessdata.fda.gov |
| Products, Red-Cell Lysing Products | GGK | 1 | Manufacturer | accessdata.fda.gov |
| Radioassay, Angiotensin Converting Enzyme | KQN | 2 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 6, 2024 | K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | NXO | Substantially Equivalent | Bühlmann Laboratories AG | accessdata.fda.gov |
| September 24, 2019 | K191718 | Buhlmann fCAL turbo and CALEX Cap | NXO | Substantially Equivalent | Buhlmann Laboratories AG | accessdata.fda.gov |
| June 25, 2019 | K190784 | BUHLMANN fCAL turbo | NXO | Substantially Equivalent | Buhlmann Laboratories AG | accessdata.fda.gov |
| June 4, 2018 | K181012 | BUHLMANN fCAL ELISA | NXO | Substantially Equivalent | Buhlmann Laboratories AG | accessdata.fda.gov |
| January 29, 2002 | K012576 | CIC-C1Q EIA | DAK | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
| August 26, 1991 | K913091 | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY | KQN | Substantially Equivalent | American Laboratory Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Formalin-Saline
- All makers of Reagents, Specific, Analyte
- All makers of Complement C1q, Antigen, Antiserum, Control
- All makers of Products, Red-Cell Lysing Products
- All makers of Radioassay, Angiotensin Converting Enzyme
- All makers of Calprotectin, Fecal
Updated February 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.