The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Actichrome Heparin (anti-fxa), Model 832.
| Device ID | K013318 |
| 510k Number | K013318 |
| Device Name: | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 |
| Classification | Assay, Heparin |
| Applicant | AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. Greenwich, CT 06830 |
| Contact | John Berryman |
| Correspondent | John Berryman AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. Greenwich, CT 06830 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-05 |
| Decision Date | 2002-03-08 |
| Summary: | summary |