Cleared Traditional

VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT

K022021 · Vital Scientific N.V. · Hematology
Nov 2002
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K022021 is an FDA 510(k) clearance for the VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Vital Scientific N.V. (Newton, US). The FDA issued a Cleared decision on November 1, 2002, 134 days after receiving the submission on June 20, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K022021 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2002
Decision Date November 01, 2002
Days to Decision 134 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GFO — Activated Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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