FDA.reportPublic FDA data

510(k) K180486

Device
HemosIL Factor XII Deficient Plasma
Applicant
Instrumentation Laboratory Co.
510(k) number
K180486
Product code
GJT  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-22
Date received
2018-02-23
Regulation
864.7290
Classification name
Plasma, Coagulation Factor Deficient
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carol Marble
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 GJT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.2023-09-13
K102851NOFACT VIIIR2 Diagnostics, Inc.2011-12-19
K102908NOFACT IXR2 Diagnostics, Inc.2011-12-19
K110237HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory CO2011-07-08
K050661HEMOSIL FACTOR II DEFICIENT PLASMAInstrumentation Laboratory CO2005-05-02
K043459HEMOSIL FACTOR XII DEFICIENT PLASMAInstrumentation Laboratory CO2005-02-09
K040362DIAPHARMA FACTOR X KITDiapharma Group, Inc.2004-07-12
K034007HEMOSIL FACTOR VIII DEFICIENT PLASMAInstrumentation Laboratory CO2004-02-13
K031829HEMOSIL FACTOR IX DEFICIENT PLASMAInstrumentation Laboratory CO2003-07-31
K031122HEMOSIL FACTOR X DEFICIENT PLASMAInstrumentation Laboratory CO2003-05-19
K030287HEMOSIL FACTOR XI DEFICIENT PLASMAInstrumentation Laboratory CO2003-03-19
K024082HEMOSIL FACTOR VII DEFICIENT PLASMAInstrumentation Laboratory CO2003-02-12
K023839HEMOSIL FACTOR V DEFICIENT PLASMAInstrumentation Laboratory CO2003-01-14
K990814CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15Precision Biologic1999-06-07
K990296CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)Precision Biologic1999-03-18

Legacy Summary#

summary

FDA Review#

Decision Summary