The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho* Rotavirus Antigen Elisa Test.
| Device ID | K883935 |
| 510k Number | K883935 |
| Device Name: | ORTHO* ROTAVIRUS ANTIGEN ELISA TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| 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 | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-19 |
| Decision Date | 1989-01-04 |