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 |