Medical Device Manufacturer · US , Greenwich , CT

American Diagnostica, Inc.

10 submissions · 10 cleared · Since 1994
10
Total
10
Cleared
0
Denied

American Diagnostica, Inc. — FDA 510(k) Submissions

American Diagnostica, Inc. has submitted 10 FDA 510(k) premarket notifications since 1994, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Qualitative And Quantitative Factor Deficiency, Assay, Heparin, Test, Time, Prothrombin, Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, Plasma, Control, Normal . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
DIMERTEST
K080069 · DAP Fibrinogen And Fibrin... · Hematology
Feb 2008 34d
SPECTROLYSE PAI-1, MODEL 101201
K063323 · GGP Test, Qualitative And... · Hematology
Aug 2007 285d
ACTICLOT, MODEL 824
K052124 · GJS Test, Time, Prothrombin · Hematology
Oct 2005 73d
ACTICHROME HEPARIN (ANTI-FIIA)
K013637 · KFF Assay, Heparin · Hematology
Apr 2002 162d
IMUBIND TPA ELISA, MODEL 860
K013492 · GGP Test, Qualitative And... · Hematology
Mar 2002 142d
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
K013318 · KFF Assay, Heparin · Hematology
Mar 2002 154d
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
K013168 · GGP Test, Qualitative And... · Hematology
Mar 2002 167d
ACTICLOT PROTEIN S, MODEL 843L
K012386 · GGP Test, Qualitative And... · Hematology
Sep 2001 49d
DV TEST AND DVV CONFIRM
K940490 · GIR Reagent, Russel Viper Venom · Hematology
Apr 1995 426d
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA
K935254 · GIZ Plasma, Control, Normal · Hematology
Sep 1994 322d
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