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510(k) K902530

Device
SPECTROLYSE ATIII KIT
Applicant
BIOPOOL AB
510(k) number
K902530
Product code
JBQ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-08-09
Date received
1990-06-05
Regulation
864.7060
Classification name
Antithrombin Iii Quantitation
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CERSKUS, PHD
Address
1016 Sutton Dr. Unit C8, Burlington Ontario, L7l 6b8 CA L7L 6B8 L7L 6B8

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JBQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH2025-03-28
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

Legacy Summary#

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FDA Review#

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