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510(k) K810058

Device
Ortho Quantitative Fibrinogen Assay
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
510(k) number
K810058
Product code
KQJ
Decision
Substantially Equivalent (SESE)
Decision date
1981-02-26
Date received
1981-01-13
Regulation
864.7340
Classification name
System, Fibrinogen Determination
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
125 Mark Ave. Carpinteria CA US 93013 93013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.2025-07-24
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