Coacute Antithrombin R Chromogenic Assay

FDA 510(k) K952515 · Chromogenix AB

Substantially Equivalent

510(k) numberK952515

Submission

Device name
Coacute Antithrombin R Chromogenic Assay
Applicant
Chromogenix AB
Franklin, OH, US
Received
May 31, 1995
Decision date
January 23, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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

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K242952INNOVANCE AntithrombinJBQ · Traditional Siemens Healthcare Diagnostic Products GmbH03/28/2025SE
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K070301Hemosil AntithrombinJBQ · Special Instrumentation Laboratory CO02/23/2007SE
K062431Hemosil Liquid AntithrombinJBQ · Special Instrumentation Laboratory CO09/01/2006SE
K043007Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105JBQ · Traditional Hyphen Biomed11/07/2005SE
K033775Hemosil Liquid Antithrombin XLJBQ · Special Instrumentation Laboratory CO01/02/2004SE
K023991Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional Precision Biologic04/28/2003SE
K022550Coamatic LR Antithrombin, Note: Lr=Liquid ReagentsJBQ · Traditional Instrumentation Laboratory CO08/27/2002SE
K022195Coamatic AT-400JBQ · Traditional Instrumentation Laboratory CO08/07/2002SE
K994238Il Test Liquid AntithrombinJBQ · Traditional Instrumentation Laboratory CO06/23/2000SE

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Questions and answers

When was Coacute Antithrombin R Chromogenic Assay cleared by the FDA?

Coacute Antithrombin R Chromogenic Assay (K952515) received a 510(k) decision of Substantially Equivalent on January 23, 1996, 237 days after the submission was received.

What is the product code of K952515?

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