FDA.report

510(k) K920258

Device
Qbc Fibrinogen
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K920258
Product code
KQJ
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-26
Date received
1992-01-21
Regulation
864.7340
Classification name
System, Fibrinogen Determination
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
RUSSELL ARNSBERGER
Address
1 Becton Dr. Franklin Lakes NJ US 07417 07417

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQJ

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
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