510(k) K181012
K181012 is an FDA 510(k) premarket notification submitted by Buhlmann Laboratories AG for the device "BUHLMANN fCAL ELISA". The FDA issued a decision of Substantially Equivalent on June 4, 2018. The device falls under product code NXO (Calprotectin, Fecal), a Class II device regulated under 21 CFR 866.5180. Buhlmann Laboratories AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2018
- Date Received
- April 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calprotectin, Fecal
- Device Class
- Class II
- Regulation Number
- 866.5180
- Review Panel
- IM
- Submission Type
The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.