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 |