---
title: fCAL® turbo RECEIVES 510(K) CLEARANCE IN THE USA
description: Gentian Diagnostics AS is pleased to announce that BÜHLMANN has received 510(k) clearance (K190784) from the FDA for the BÜHLMANN fCAL® turbo. BÜHLMANN is Gentian’s exclusive commercial partner for th
---

<https://www.gentian.com/investor-relations-stock-information/investors-news>

# [fCAL® turbo RECEIVES 510(K) CLEARANCE IN THE USA](https://www.gentian.com/investor-relations-stock-information/investors-news/fcal-turbo-receives-510k-clearance-in-the-usa)

 Written by [Kristin Hart](https://www.gentian.com/investor-relations-stock-information/investors-news/author/kristin-hart) | Jun 28, 2019 6:55:04 AM

Moss, 28.06.2019

Gentian Diagnostics AS is pleased to announce that BÜHLMANN has received 510(k) clearance (K190784) from the FDA for the BÜHLMANN fCAL® turbo. BÜHLMANN is Gentian’s exclusive commercial partner for the fecal calprotectin products worldwide.

 

The potential US fecal calprotectin market is of an estimated size of USD ~30 million, while the current market is of an estimated size of USD ~5 million. Hilja Ibert, CEO Gentian Diagnostics AS comments “While the fecal calprotectin market size in the US is still quite small, fecal calprotectin is part of a high annual growth market, as observed in Europe. The already FDA cleared BÜHLMANN fCAL® ELISA has paved the way for BÜHLMANN fCAL® turbo which will allow for high throughput analysis of fecal calprotectin in applicable core laboratories and screening programmes.”

 

**For further information, please contact:**

 

Hilja Ibert CEO

Gentian Diagnostics AS   
E-mail: [hilja.ibert@gentian.no](mailto:hilja.ibert@gentian.no)   
Cell Phone: +47 919 05 242

 

Njaal Kind CFO,

Gentian Diagnostics AS   
E-mail: [njaal.kind@gentian.no](mailto:njaal.kind@gentian.no)   
Cell Phone: +47 919 06 525

 

**MeldingsID: ** 480471

 

[View full post](https://www.gentian.com/investor-relations-stock-information/investors-news/fcal-turbo-receives-510k-clearance-in-the-usa)

```json
{
  "@context" : "http://schema.org",
  "@type" : "BlogPosting",
  "author" : {
    "@type" : "Person",
    "name" : "Kristin Hart"
  },
  "dateModified" : "2019-12-10T12:56:31.177Z",
  "datePublished" : "2019-06-28T06:55:04Z",
  "headline" : "fCAL® turbo RECEIVES 510(K) CLEARANCE IN THE USA",
  "image" : {
    "@type" : "ImageObject",
    "height" : 60,
    "url" : "/hs/hsstatic/content_shared_assets/static-1.4092/img/default-amp-logo.png",
    "width" : 60
  },
  "mainEntityOfPage" : "https://www.gentian.com/investor-relations-stock-information/investors-news/fcal-turbo-receives-510k-clearance-in-the-usa",
  "publisher" : {
    "@type" : "Organization",
    "logo" : {
      "@type" : "ImageObject",
      "height" : 60,
      "url" : "/hs/hsstatic/content_shared_assets/static-1.4092/img/default-amp-logo.png",
      "width" : 60
    },
    "name" : "Investor News"
  }
}
```