VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT— 510(k) K022021

Name: FDA 510(k) clearance K022021
Creator: U.S. Food and Drug Administration
Published: 2002-11-01

Substantially Equivalent

Vital Scientific N.V.

FDA 510(k) clearance K022021 for VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT, Substantially Equivalent on 2002-11-01. Applicant: Vital Scientific N.V.. Device class: 2.

Clearance details

Applicant: Vital Scientific N.V.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2002-06-20
Decision date: 2002-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GFO

view all

K253957 — HemosIL Silica Clotting Time2026-01-09
K193556 — Cryocheck Hex LA2020-10-23
K160445 — HemosIL Silica Clotting Time2016-03-16
K053111 — STA-CEPHASCREEN KIT2006-05-04
K060688 — HEMOSIL SYNTHASIL2006-04-13

More clearances from Vital Scientific N.V.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.