The following data is part of a premarket notification filed by American Dade with the FDA for Data-fi Dimertest Latex Assay.
| Device ID | K872195 |
| 510k Number | K872195 |
| Device Name: | DATA-FI DIMERTEST LATEX ASSAY |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Karen H Darcy |
| Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-08 |
| Decision Date | 1987-08-06 |