The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Visible-herpes Tm Test System.
| Device ID | K854712 |
| 510k Number | K854712 |
| Device Name: | VISIBLE-HERPES TM TEST SYSTEM |
| Classification | Antisera, Cf, Herpesvirus Hominis 1,2 |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Loren F Hazelwood |
| Correspondent | Loren F Hazelwood ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | GQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-22 |
| Decision Date | 1986-05-20 |