The following data is part of a premarket notification filed by Bartels & Stout, Inc. with the FDA for Direct Fluorescent Antibody Kit/herpes.
| Device ID | K802590 |
| 510k Number | K802590 |
| Device Name: | DIRECT FLUORESCENT ANTIBODY KIT/HERPES |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | BARTELS & STOUT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1981-02-09 |