Medical Device Manufacturer · ES , Barcelona

Biosystems S.A. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2018

Recent clearances: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV, Transferrin, alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biosystems S.A. Chemistry ✕

3 devices

1-3 of 3

Cleared Sep 09, 2020

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV

Chemistry · 348d

Cleared May 02, 2019

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN...

Chemistry · 234d

Cleared Apr 13, 2018

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

Chemistry · 382d