Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Biosystems S.A. with 7 510(k) clearances. The most recent is a 510(k) clearance dated Sep 9, 2020: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 9, 2020 | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UVK192730 · CHW | 510(k) clearances |
| Mar 16, 2020 | TransferrinK190495 · DDG | 510(k) clearances |
| May 2, 2019 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALK182474 · JFJ | 510(k) clearances |
| Apr 13, 2018 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400K170901 · CIX | 510(k) clearances |
| Aug 24, 1995 | BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)K950897 · MMK | 510(k) clearances |
| Aug 24, 1995 | BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE)K950898 · MMK | 510(k) clearances |
| Jun 29, 1995 | LABORATORY SHARPS BARRELK950899 · FMI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
