The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for D-dimer Wellcotest (ha10).
| Device ID | K915203 |
| 510k Number | K915203 |
| Device Name: | D-DIMER WELLCOTEST (HA10) |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Contact | Kafader Ii |
| Correspondent | Kafader Ii WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-18 |
| Decision Date | 1992-01-31 |