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510(k) K962671

Device
STA-VWF CALIBRATOR KIT
Applicant
AMERICAN BIOPRODUCTS CO.
510(k) number
K962671
Product code
GJT  
Decision
Substantially Equivalent (SESE)
Decision date
1996-09-13
Date received
1996-07-09
Regulation
864.7290
Classification name
Plasma, Coagulation Factor Deficient
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANDREW LOC B. LE
Address
5 Century Dr. Parisppany NJ US 07054 07054

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
K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory CO2018-03-22
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

Legacy Summary#

summary

FDA Review#

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