The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho* Syphilis-m Antibody Elisa Test.
| Device ID | K883938 |
| 510k Number | K883938 |
| Device Name: | ORTHO* SYPHILIS-M ANTIBODY ELISA TEST |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Contact | Larry D Mcclain,phd |
| Correspondent | Larry D Mcclain,phd ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-19 |
| Decision Date | 1988-12-22 |