American Diagnostica, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K080069 | DIMERTEST | February 13, 2008 |
| K063323 | SPECTROLYSE PAI-1, MODEL 101201 | August 15, 2007 |
| K052124 | ACTICLOT, MODEL 824 | October 17, 2005 |
| K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | April 16, 2002 |
| K013492 | IMUBIND TPA ELISA, MODEL 860 | March 13, 2002 |
| K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | March 8, 2002 |
| K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 | March 7, 2002 |
| K012386 | ACTICLOT PROTEIN S, MODEL 843L | September 14, 2001 |
| K940490 | DV TEST AND DVV CONFIRM | April 5, 1995 |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | September 19, 1994 |