The following data is part of a premarket notification filed by California Integrated Diagnostics, Inc. with the FDA for Herpes Simplex Virus Tissue Culture Conf. Typing.
| Device ID | K904095 |
| 510k Number | K904095 |
| Device Name: | HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | CALIFORNIA INTEGRATED DIAGNOSTICS, INC. 433 INDUSTRIAL WAY Benica, CA 94510 |
| Contact | Susan C Fuller |
| Correspondent | Susan C Fuller CALIFORNIA INTEGRATED DIAGNOSTICS, INC. 433 INDUSTRIAL WAY Benica, CA 94510 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1991-02-01 |