BIOTROL BICARBONATE STANDARDS— 510(k) K921855

Name: FDA 510(k) clearance K921855
Creator: U.S. Food and Drug Administration
Published: 1992-08-03

Substantially Equivalent

Biotrol, USA, Inc.

FDA 510(k) clearance K921855 for BIOTROL BICARBONATE STANDARDS, Substantially Equivalent on 1992-08-03. Applicant: Biotrol, USA, Inc.. Device class: 2.

Clearance details

Applicant: Biotrol, USA, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1992-04-17
Decision date: 1992-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

Download summary PDF View on FDA.gov ↗

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