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510(k) K242952

Device
INNOVANCE Antithrombin
Applicant
Siemens Healthcare Diagnostic Products GmbH
510(k) number
K242952
Product code
JBQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-28
Date received
2024-09-25
Regulation
864.7060
Classification name
Antithrombin Iii Quantitation
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Martina Pfeiff
Address
Emil-Von-Behring Strasse 76 Marburg DE 35041 35041

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JBQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare Diagnostics2009-05-28
K070301HEMOSIL ANTITHROMBINInstrumentation Laboratory CO2007-02-23
K062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory CO2006-09-01
K043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen Biomed2005-11-07
K033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation Laboratory CO2004-01-02
K023991CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50Precision Biologic2003-04-28
K022550COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTSInstrumentation Laboratory CO2002-08-27
K022195COAMATIC AT-400Instrumentation Laboratory CO2002-08-07
K994238IL TEST LIQUID ANTITHROMBINInstrumentation Laboratory CO2000-06-23
K000361K-ASSAY AT-IIIKamiya Biomedical Co.2000-04-26
K980499IL TEST ANTITHROMBINInstrumentation Laboratory CO1998-04-02
K974110IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENTBeckman Instruments, Inc.1997-12-24
K972144SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN IIISigma Diagnostics, Inc.1997-07-25
K960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)Medical Diagnostic Technologies, Inc.1996-08-14
K952515COACUTE ANTITHROMBIN R CHROMOGENIC ASSAYChromogenix AB1996-01-23