Thrombo-Screen AT-111 Kit

Q: What is the product code of K770394?

The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.

FDA 510(k) K770394 · Bay Area Hema. Onco. Clinic. & Res. L

Substantially Equivalent

510(k) numberK770394

Submission

Device name: Thrombo-Screen AT-111 Kit
Applicant: Bay Area Hema. Onco. Clinic. & Res. L
Mchenry, IL, US
Received: February 28, 1977
Decision date: March 30, 1977
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: JBQ – Antithrombin Iii Quantitation
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.7060
Specialty: Hematology

Other 510(k)s with product code JBQ

510(k)	Device	Applicant	Decision
K242952	INNOVANCE AntithrombinJBQ · Traditional	Siemens Healthcare Diagnostic Products GmbH	03/28/2025SE
K081769	Innovance Antithrombin with Models OPFH03, OPFHO5JBQ · Traditional	Siemens Healthcare Diagnostics	05/28/2009SE
K070301	Hemosil AntithrombinJBQ · Special	Instrumentation Laboratory CO	02/23/2007SE
K062431	Hemosil Liquid AntithrombinJBQ · Special	Instrumentation Laboratory CO	09/01/2006SE
K043007	Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105JBQ · Traditional	Hyphen Biomed	11/07/2005SE
K033775	Hemosil Liquid Antithrombin XLJBQ · Special	Instrumentation Laboratory CO	01/02/2004SE
K023991	Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional	Precision Biologic	04/28/2003SE
K022550	Coamatic LR Antithrombin, Note: Lr=Liquid ReagentsJBQ · Traditional	Instrumentation Laboratory CO	08/27/2002SE
K022195	Coamatic AT-400JBQ · Traditional	Instrumentation Laboratory CO	08/07/2002SE
K994238	Il Test Liquid AntithrombinJBQ · Traditional	Instrumentation Laboratory CO	06/23/2000SE

More from Instrumentation Laboratory CO

510(k)	Device	Decision
K771678	Thrombo-Screen Platelet AdhesionJBZ · Traditional	11/22/1977SE
K770722	Thrombo Screen Quantitative Heparin AssaJBR · Traditional	07/11/1977SE
K770395	Thrombo-Cetin (Ristocetin)JOZ · Traditional	03/21/1977SE

Questions and answers

When was Thrombo-Screen AT-111 Kit cleared by the FDA?

Thrombo-Screen AT-111 Kit (K770394) received a 510(k) decision of Substantially Equivalent on March 30, 1977, 30 days after the submission was received.

What is the product code of K770394?

The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.