Cleared Traditional

TAS A PTT TEST CONTROLS

K961189 · Cardiovascular Diagnostics, Inc. · Hematology
Jun 1996
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K961189 is an FDA 510(k) clearance for the TAS A PTT TEST CONTROLS, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on June 5, 1996, 71 days after receiving the submission on March 26, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K961189 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1996
Decision Date June 05, 1996
Days to Decision 71 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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