The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Imagen Herpes Simplex Virus (hsv) Typing Test.
| Device ID | K870602 |
| 510k Number | K870602 |
| Device Name: | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Contact | John G Simpson |
| Correspondent | John G Simpson BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-11 |
| Decision Date | 1987-05-08 |