The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Cultureset Hsv Isolation & Id Sys.
| Device ID | K842216 |
| 510k Number | K842216 |
| Device Name: | CULTURESET HSV ISOLATION & ID SYS |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Contact | Larry D Mcclain |
| Correspondent | Larry D Mcclain ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE 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 | 1984-06-04 |
| Decision Date | 1985-01-29 |