The following data is part of a premarket notification filed by Buhlmann Laboratories Ag with the FDA for Buhlmann Fcal Elisa.
| Device ID | K181012 |
| 510k Number | K181012 |
| Device Name: | BUHLMANN FCAL ELISA |
| Classification | Calprotectin, Fecal |
| Applicant | BUHLMANN Laboratories AG Baselstrasse 55 Schonenbuch, CH Ch-4124 |
| Contact | Alicja Ritz |
| Correspondent | Roshana Ahmed Mapi SRS, An ICON Plc Company 2343 Alexandria Drive Suite 100 Lexington, KY 40504 |
| Product Code | NXO |
| CFR Regulation Number | 866.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-17 |
| Decision Date | 2018-06-04 |
| Summary: | summary |