The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcozyme Hsv Wzo2.
Device ID | K875311 |
510k Number | K875311 |
Device Name: | WELLCOZYME HSV WZO2 |
Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
Contact | Moody, Phd |
Correspondent | Moody, Phd WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
Product Code | GQN |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-29 |
Decision Date | 1988-08-03 |