Cleared Traditional

B-FACT, BORDERLINE FACTOR ASSAY CONTROL

K945854 · George King Bio-Medical, Inc. · Hematology
Oct 1995
Decision
344d
Days
Class 2
Risk

About This 510(k) Submission

K945854 is an FDA 510(k) clearance for the B-FACT, BORDERLINE FACTOR ASSAY CONTROL, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by George King Bio-Medical, Inc. (Overland Park, US). The FDA issued a Cleared decision on October 24, 1995, 344 days after receiving the submission on November 14, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K945854 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1994
Decision Date October 24, 1995
Days to Decision 344 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

Similar Devices — GGN Plasma, Coagulation Control

All 98
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
K170864 · Maine Standards Company, LLC · Jun 2017
VALIDATE Heparin Calibration Verification/Linearity Test Kit
K163498 · Maine Standards Company, LLC · Mar 2017
George King Coumadin Plasma
K161316 · George King Bio-Medical, Inc. · Feb 2017
VALIDATE? D-Dimer Calibration Verification/ Linearity Test Kit
K162705 · Maine Standards Company, LLC · Jan 2017
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
K152961 · Maine Standards Company, LLC · Jun 2016
VisuCon-F Low Fibrinogen Control Plasma
K150144 · Affinity Biologicals, Inc. · Mar 2016