Company ยท ES
Biosystems S.A.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2020. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2020 | K192730 | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV Biosystems S.A., ES | CHW |
| Mar 16, 2020 | K190495 | Transferrin Biosystems S.A., ES | DDG |
| May 2, 2019 | K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL Biosystems S.A., ES | JFJ |
| Apr 13, 2018 | K170901 | ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 Biosystems S.A., ES | CIX |
| Aug 24, 1995 | K950898 | BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE) Biosystems | MMK |
| Aug 24, 1995 | K950897 | BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) Biosystems | MMK |
| Jun 29, 1995 | K950899 | LABORATORY SHARPS BARREL Biosystems | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||