CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV— 510(k) K192730

Substantially Equivalent

Biosystems S.A.

FDA 510(k) clearance K192730 for CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV, Substantially Equivalent on 2020-09-09. Applicant: Biosystems S.A..

Clearance details

Applicant: Biosystems S.A.
Product code: Code CHW
Advisory panel: Clinical Chemistry
Date received: 2019-09-27
Decision date: 2020-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.