FDA.report

510(k) K251968

Device
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
Applicant
Instrumentation Laboratory (IL) Co.
510(k) number
K251968
Product code
KQJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-24
Date received
2025-06-26
Regulation
864.7340
Classification name
System, Fibrinogen Determination
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Kirivann Chhoeun
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code KQJ

510(k)DeviceApplicantDecision date
K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory CO2007-12-27
K050928DADE THROMBIN REAGENTDade Behring, Inc.2005-06-29
K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.1997-10-09
K970189FIF TMPanbio, Inc.1997-05-21
K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat Diagnostics, Inc.1997-04-16
K934326MULTIFIBREN UBehring Diagnostics, Inc.1994-04-19
K931721IL TEST FIBRINOGEN-CInstrumentation Laboratory CO1993-08-13
K922416FIBRINOGEN RID TEST KITThe Binding Site, Ltd.1993-03-09
K925988MULTIFIBRENBehring Diagnostics, Inc.1993-03-01
K923593HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLASInternational Technidyne Corp.1992-09-22
K920258QBC FIBRINOGENBd Becton Dickinson Vacutainer Systems Preanalytic1992-06-26
K900939SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)Incstar Corp.1990-05-16
K900895COAG-A-MATE - RA4Organon Teknika Corp.1990-04-16
K896052FIBRINOGEN ASSAY KITMedical Diagnostic Technologies, Inc.1989-11-09
K884179TURBOX FIBRINOGENUnipath , Ltd.1988-12-20