The following data is part of a premarket notification filed by Genus Diagnostics with the FDA for Hsv Idr.
Device ID | K854974 |
510k Number | K854974 |
Device Name: | HSV IDR |
Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
Applicant | GENUS DIAGNOSTICS 225 WILDWOOD ST. Woburn, MA 01801 |
Contact | Mark P Bear |
Correspondent | Mark P Bear GENUS DIAGNOSTICS 225 WILDWOOD ST. Woburn, MA 01801 |
Product Code | GQN |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-12 |
Decision Date | 1986-03-07 |