BIOTROL PROTEIN MULTILEVEL STANDARDS— 510(k) K910721

Name: FDA 510(k) clearance K910721
Creator: U.S. Food and Drug Administration
Published: 1991-05-06

Substantially Equivalent

Biotrol, USA, Inc.

FDA 510(k) clearance K910721 for BIOTROL PROTEIN MULTILEVEL STANDARDS, Substantially Equivalent on 1991-05-06. 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: 1991-02-20
Decision date: 1991-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westchester, PA, US

Download summary PDF View on FDA.gov ↗

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