Cleared Traditional

FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON

K021976 · Vital Scientific N.V. · Hematology
Oct 2002
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K021976 is an FDA 510(k) clearance for the FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON, a Instrument, Coagulation (Class II — Special Controls, product code KQG), submitted by Vital Scientific N.V. (Newton, US). The FDA issued a Cleared decision on October 25, 2002, 130 days after receiving the submission on June 17, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K021976 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2002
Decision Date October 25, 2002
Days to Decision 130 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KQG — Instrument, Coagulation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5400

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