The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Viral Transport.
| Device ID | K853500 |
| 510k Number | K853500 |
| Device Name: | ORTHO VIRAL TRANSPORT |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Contact | Larry D Mcclain |
| Correspondent | Larry D Mcclain ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1985-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101410 | K853500 | 000 |