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510(k) K190784

BUHLMANN fCAL turbo by Buhlmann Laboratories AG — Product Code NXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2019
Date Received
March 27, 2019
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.

Other clearances by Buhlmann Laboratories AG

  • K191718 — Buhlmann fCAL turbo and CALEX Cap (September 24, 2019)
  • K181012 — BUHLMANN fCAL ELISA (June 4, 2018)
  • K954299 — BUHLMANN ANGIOSTENSIN II RIA (October 19, 1995)

Other clearances for product code NXO

  • K232057 — BÜHLMANN fCAL® turbo and CALEX® Cap (February 6, 2024)
  • K220763 — ALPCO Calprotectin Immunoturbidimetric Assay (April 13, 2023)
  • K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (July 26, 2022)
  • K191807 — ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device (October 25, 2019)
  • K191718 — Buhlmann fCAL turbo and CALEX Cap (September 24, 2019)
  • K191589 — Calprest, EasyCal (July 10, 2019)
  • K191592 — CalprestNG, EasyCal (July 10, 2019)
  • K182698 — LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Cal (December 26, 2018)
  • K180971 — QUANTA Flash Calprotectin and Fecal Extraction Device (October 16, 2018)
  • K181012 — BUHLMANN fCAL ELISA (June 4, 2018)