FDA 510(k) Applications Submitted by AMERICAN DIAGNOSTICA, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K063323 |
11/03/2006 |
SPECTROLYSE PAI-1, MODEL 101201 |
AMERICAN DIAGNOSTICA, INC. |
| K013318 |
10/05/2001 |
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 |
AMERICAN DIAGNOSTICA, INC. |
| K013637 |
11/05/2001 |
ACTICHROME HEPARIN (ANTI-FIIA) |
AMERICAN DIAGNOSTICA, INC. |
| K012386 |
07/27/2001 |
ACTICLOT PROTEIN S, MODEL 843L |
AMERICAN DIAGNOSTICA, INC. |
| K013168 |
09/21/2001 |
IMUBIND PLASMA PAI-1 ELISA,MODEL 822 |
AMERICAN DIAGNOSTICA, INC. |
| K013492 |
10/22/2001 |
IMUBIND TPA ELISA, MODEL 860 |
AMERICAN DIAGNOSTICA, INC. |
| K080069 |
01/10/2008 |
DIMERTEST |
AMERICAN DIAGNOSTICA, INC. |
| K052124 |
08/05/2005 |
ACTICLOT, MODEL 824 |
AMERICAN DIAGNOSTICA, INC. |
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