Hemochron Electronic System Verification Tube

Q: What is the product code of K990449?

The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.

FDA 510(k) K990449 · International Technidyne Corp.

Substantially Equivalent

510(k) numberK990449

Submission

Device name: Hemochron Electronic System Verification Tube
Applicant: International Technidyne Corp.
Edison, NJ, US
Received: February 12, 1999
Decision date: April 13, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JPA – System, Multipurpose For In Vitro Coagulation Studies
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.5425
Specialty: Hematology

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K202101	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…JPA · Traditional	Accriva Diagnostics, Inc.	12/29/2021SE

More from Accriva Diagnostics, Inc.

510(k)	Device	Decision
K120977	Directcheck Control for Hemochron Jr. Microcoagulation Systems Act-Lr Cuvette…GGN · Traditional	07/03/2013SE
K050983	Irma Trupoint Creatinine Control KitJJX · Traditional	05/16/2005SE
K050016	Hemochron Signature EliteJPA · Traditional	02/10/2005SE
K030818	Hemochron Response/SystemJPA · Special	04/02/2003SE
K023561	Itc HGB Pro Professional Hemoglobin Testing SystemGKR · Traditional	01/31/2003SE
K020798	Hemochron Jr. Signature +JPA · Special	03/28/2002SE
K010599	Protime Microcoagulation System / Protime 3 CuvetteGJS · Special	07/02/2001SE
K010193	Hemochron Kaolin-Activated Heparin and Protamine Dosing AssaysKFF · Traditional	06/06/2001SE
K983475	Hemochron ResponseKQG · Traditional	05/03/1999SE
K972866	Hemochron Jr. Miocrocoagulation Citrated PTGJS · Traditional	09/30/1998SE

Questions and answers

When was Hemochron Electronic System Verification Tube cleared by the FDA?

Hemochron Electronic System Verification Tube (K990449) received a 510(k) decision of Substantially Equivalent on April 13, 1999, 60 days after the submission was received.

What is the product code of K990449?

The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.