Company ยท US
American Diagnostica, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2008. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 2008 | K080069 | DIMERTEST American Diagnostica, Inc. | DAP |
| Aug 15, 2007 | K063323 | SPECTROLYSE PAI-1, MODEL 101201 American Diagnostica, Inc. | GGP |
| Oct 17, 2005 | K052124 | ACTICLOT, MODEL 824 American Diagnostica, Inc. | GJS |
| Apr 16, 2002 | K013637 | ACTICHROME HEPARIN (ANTI-FIIA) American Diagnostica, Inc. | KFF |
| Mar 13, 2002 | K013492 | IMUBIND TPA ELISA, MODEL 860 American Diagnostica, Inc. | GGP |
| Mar 8, 2002 | K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 American Diagnostica, Inc. | KFF |
| Mar 7, 2002 | K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 American Diagnostica, Inc. | GGP |
| Sep 14, 2001 | K012386 | ACTICLOT PROTEIN S, MODEL 843L American Diagnostica, Inc. | GGP |
| Apr 5, 1995 | K940490 | DV TEST AND DVV CONFIRM American Diagnostica, Inc. | GIR |
| Sep 19, 1994 | K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA American Diagnostica, Inc. | GIZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2010 | American Diagnostica, Inc. REF 822 IMUBIND(R) Plasma PAI-1 ELISA
The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen Terminated |
GGP | K013168 |
| May 3, 2007 | American Diagnostica, Inc. American Diagnostica Inc. ACTICLOT dPT
Reference 824 in vitro diagnostic Terminated |
GIR | K052124 |