The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Mda D-dimer.
| Device ID | K974776 |
| 510k Number | K974776 |
| Device Name: | MDA D-DIMER |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Ron Sanyal |
| Correspondent | Ron Sanyal ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-04-16 |
| Summary: | summary |