The following data is part of a premarket notification filed by Buhlmann Laboratories Ag with the FDA for Buhlmann Fcal Turbo.
| Device ID | K190784 |
| 510k Number | K190784 |
| Device Name: | BUHLMANN FCAL Turbo |
| Classification | Calprotectin, Fecal |
| Applicant | BUHLMANN Laboratories AG Baselstrasse 55 Schonenbuch, CH 4124 |
| Contact | Laura Zurbrugg |
| Correspondent | Roshana Ahmed QUARAS, LLC 2101 Camino Rey Fullerton, CA 92833 |
| Product Code | NXO |
| CFR Regulation Number | 866.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-27 |
| Decision Date | 2019-06-25 |