I-Stat Coagulation Control Set

FDA 510(k) K981752 · Biopool Intl., Inc.

Substantially Equivalent

510(k) numberK981752

Submission

Device name
I-Stat Coagulation Control Set
Applicant
Biopool Intl., Inc.
Ventura, CA, US
Received
May 18, 1998
Decision date
June 15, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GGN – Plasma, Coagulation Control
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5425
Specialty
Hematology

Other 510(k)s with product code GGN

510(k)DeviceApplicantDecision
K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitGGN · Traditional Maine Standards Company, LLC06/21/2017SE
K163498VALIDATE Heparin Calibration Verification/Linearity Test KitGGN · Traditional Maine Standards Company, LLC03/16/2017SE
K161316George King Coumadin PlasmaGGN · Traditional George King Bio-Medical, Inc.02/23/2017SE
K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitGGN · Traditional Maine Standards Company, LLC01/05/2017SE
K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitGGN · Traditional Maine Standards Company, LLC06/03/2016SE
K150144VisuCon-F Low Fibrinogen Control PlasmaGGN · Traditional Affinity Biologicals, Inc.03/06/2016SE
K142132Pool NormGGN · Traditional Diagnostics Stago S.A.S.12/12/2014SE
K133582Hemosil D-Dimer HS 500 ControlGGN · Traditional Instrumentation Laboratory08/15/2014SE
K120977Directcheck Control for Hemochron Jr. Microcoagulation Systems Act-Lr Cuvette…GGN · Traditional International Technidyne Corp.07/03/2013SE
K120900I-Stat PT Control Leviel 1 I-Stat PT Control Level 2GGN · Traditional Cliniqa Corporation05/31/2013SE

More from Cliniqa Corporation

510(k)DeviceDecision
K002642Miniquant D-Dimer, Model 1447DAP · Traditional 02/05/2001SE
K983898Bioclot Apc SensitivityGGP · Traditional 01/06/1999SE
K980314Fetal D Tection KitLIM · Traditional 04/08/1998SE

Questions and answers

When was I-Stat Coagulation Control Set cleared by the FDA?

I-Stat Coagulation Control Set (K981752) received a 510(k) decision of Substantially Equivalent on June 15, 1998, 28 days after the submission was received.

What is the product code of K981752?

The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.