ClearanceBrief
Panels › Hematology › Product code GJT · Class 2

Plasma, Coagulation Factor Deficient

Regulation 864.7290

0510(k)s in 12 months (79 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
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Top companies in GJT

Company510(k)sRecalls
Instrumentation Laboratory CO100
Medical Diagnostic Technologies, Inc.100
American Bioproducts Co.90
Sigma Chemical Co.80
Precision Biologicals, Inc.70
Biomerieux Vitek, Inc.50
Ortho Diagnostic Systems, Inc.50
Sigma Diagnostics, Inc.40
Behring Diagnostics, Inc.30
Precision Biologic30
DateFirm and productCodeLinked 510(k)
Jun 5, 2015Siemens Healthcare Diagnostics, Inc.
Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
Terminated		 GJTK924396
Mar 14, 2013Diagnostica Stago, Inc.
Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00
Terminated		 GJTK962675
Aug 16, 2005Dade Behring , Inc.
Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
Terminated		 GJTK924396

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