The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Cellmatics Herpes Simplex Virus Detect-sys.
| Device ID | K851372 |
| 510k Number | K851372 |
| Device Name: | CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | Walter S Fisher |
| Correspondent | Walter S Fisher DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-08 |
| Decision Date | 1985-07-12 |