The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Hsv 1&2 Dichromatic Typing Reagent & Slides.
| Device ID | K891382 |
| 510k Number | K891382 |
| Device Name: | ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Contact | Mcclain, Phd |
| Correspondent | Mcclain, Phd ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-09 |
| Decision Date | 1989-06-06 |