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JBQ — Antithrombin Iii Quantitation Class II

FDA Device Classification

Classification Details

Product Code
JBQ
Device Class
Class II
Regulation Number
864.7060
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242952siemens healthcare diagnostic productsINNOVANCE AntithrombinMarch 28, 2025
K081769siemens healthcare diagnosticsINNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5May 28, 2009
K070301instrumentation laboratoryHEMOSIL ANTITHROMBINFebruary 23, 2007
K062431instrumentation laboratoryHEMOSIL LIQUID ANTITHROMBINSeptember 1, 2006
K043007hyphen biomedBIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE November 7, 2005
K033775instrumentation laboratoryHEMOSIL LIQUID ANTITHROMBIN XLJanuary 2, 2004
K023991precision biologicCHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50April 28, 2003
K022550instrumentation laboratoryCOAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTSAugust 27, 2002
K022195instrumentation laboratoryCOAMATIC AT-400August 7, 2002
K994238instrumentation laboratoryIL TEST LIQUID ANTITHROMBINJune 23, 2000
K000361kamiya biomedicalK-ASSAY AT-IIIApril 26, 2000
K980499instrumentation laboratoryIL TEST ANTITHROMBINApril 2, 1998
K974110beckman instrumentsIMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENTDecember 24, 1997
K972144sigma diagnosticsSIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN IIIJuly 25, 1997
K960871medical diagnostic technologiesSPECTROLYSE ANTITHROMBIN III (ANTI-XA)August 14, 1996
K952515chromogenixCOACUTE ANTITHROMBIN R CHROMOGENIC ASSAYJanuary 23, 1996
K951943helena laboratoriesCHROM Z CHROMOGENIC ASSAYSNovember 13, 1995
K944279american bioproductsAT-III CALIBRATORApril 7, 1995
K934156biomerieux vitekBIOMERIEUX HEMOLAB AT IIIDecember 22, 1994
K935308sigma diagnosticsACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAYMay 17, 1994