Control Plasma LMW Heparin

FDA 510(k) K030965 · Instrumentation Laboratory CO

Substantially Equivalent

510(k) numberK030965

Submission

Device name
Control Plasma LMW Heparin
Applicant
Instrumentation Laboratory CO
Bedford, MA, US
Received
March 27, 2003
Decision date
June 6, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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
K233790Acl Top 970 CLJPA · Special 12/29/2023SE
K230852HemosIL Chromogenic Factor IXGGP · Traditional 12/13/2023SE
K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional 09/29/2023SE
K223608GEM Premier 7000 with IQM3CHL · Traditional 08/10/2023SE
K223187HemosIL Liquid Anti-XaQLU · Traditional 06/23/2023SE
K231031ACL TOP Family 70 SeriesGKP · Traditional 06/21/2023SE
K223090GEM Premier ChemSTATCGA · Special 01/27/2023SE
K223402HemosIL von Willebrand Factor AntigenGGP · Special 12/09/2022SE
K213464HemosIL Liquid Anti-XaKFF · Special 10/04/2022SE
K213426HemosIL ReadiPlasTinGJS · Traditional 08/16/2022SE

Questions and answers

When was Control Plasma LMW Heparin cleared by the FDA?

Control Plasma LMW Heparin (K030965) received a 510(k) decision of Substantially Equivalent on June 6, 2003, 71 days after the submission was received.

What is the product code of K030965?

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