FDA 510(k) Cleared Archives - Buhlmann Diagnostics Corp

Tag: FDA 510(k) Cleared

BÜHLMANN Laboratories AG Announces Worldwide Collaboration with Beckman Coulter for BÜHLMANN fCAL turbo and fPELA turbo Assays

Amherst NH, September 2024- BÜHLMANN Laboratories AG, a leading manufacturer of specialty, high-quality in-vitro diagnostic and research assays, is pleased to announce the collaboration with Beckman Coulter for a worldwide distribution of the BÜHLMANN fCAL® turbo assay & BÜHLMANN fPELA® turbo assay on their clinical chemistry analyzers (AU480, AU680, AU5800, and DxC 700 AU) with
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BÜHLMANN Laboratories AG Receives FDA Clearance for CALEX®Cap Stool Preparation Device

BÜHLMANN CALEX® Cap, a single use tube intended for the preparation of human stool samples to be used with the BÜHLMANN fCAL® turbo, has received 510(k) clearance from the Food and Drug Administration (FDA) and is now commercially available in the US. Amherst NH, 2019: BÜHLMANN Laboratories AG, is proud to announce it received United
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BÜHLMANN Laboratories AG Receives FDA Clearance for its fCAL® turbo Automated Calprotectin Test

BÜHLMANN fCAL® turbo, an in vitro diagnostic assay intended for the quantitation of calprotectin in human stool, has received 510(k) clearance from the Food and Drug Administration (FDA) and is now commercially available in the US. Amherst NH, June 26, 2019: BÜHLMANN Laboratories AG, is proud to announce it received United States Food and Drug
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BÜHLMANN Laboratories AG Receives FDA Clearance for its fCAL® ELISA Calprotectin Test

BÜHLMANN fCAL® ELISA, an in vitro diagnostic assay intended for the quantitation of calprotectin in human stool, has received 510(k) clearance from the Food and Drug Administration (FDA) and is now commercially available in the US. Amherst NH, June 12, 2018: BÜHLMANN Laboratories AG, is proud to announce it has received United States Food and
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