# Biosystems S.A.

- Location (FDA's records): Barcelona, ES
- FDA decisions: 7 (1995–2020): 7 510(k) clearances
- Names in FDA's records: Biosystems S.A. (4); Biosystems (3)
- Product codes: MMK (2), DDG (1), FMI (1), CHW (1), JFJ (1), CIX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Triumvirate Environmental, Inc.: 2 (https://510kreport.com/company/triumvirate-environmental)

## Its most-cited devices
- K950898: Biobox with Funnel Top (Small, Medium, Large, and X-Large) (1995), cited by 1
- K950897: Biobox Traptop (Small, Medium, Large and X-Large) (1995), cited by 1

## Recent decisions
- K192730: Calcium-Cresolphthalein, Glucose, Urea/Bun-UV (Sep 9, 2020)
- K190495: Transferrin (Mar 16, 2020)
- K182474: alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL (May 2, 2019)
- K170901: Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, BA400 (Apr 13, 2018)
- K950898: Biobox with Funnel Top (Small, Medium, Large, and X-Large) (Aug 24, 1995)
- K950897: Biobox Traptop (Small, Medium, Large and X-Large) (Aug 24, 1995)
- K950899: Laboratory Sharps Barrel (Jun 29, 1995)

Source page: https://510kreport.com/company/biosystems