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

Name: FDA 510(k) clearance K192730
Creator: U.S. Food and Drug Administration
Published: 2020-09-09

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.. Device class: 2.

Clearance details

Applicant: Biosystems S.A.
Product code: Code CHW
Device class: Class 2
Regulation: 21 CFR 862.1145
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 ↗

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