FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON— 510(k) K021976

Name: FDA 510(k) clearance K021976
Creator: U.S. Food and Drug Administration
Published: 2002-10-25

Substantially Equivalent

Vital Scientific N.V.

FDA 510(k) clearance K021976 for FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON, Substantially Equivalent on 2002-10-25. Applicant: Vital Scientific N.V.. Device class: 2.

Clearance details

Applicant: Vital Scientific N.V.
Product code: Code KQG
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Date received: 2002-06-17
Decision date: 2002-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

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