The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho* Chlamydia Antigen Elisa Test/modification.
| Device ID | K910668 |
| 510k Number | K910668 |
| Device Name: | ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Contact | Kim W Gray |
| Correspondent | Kim W Gray ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-03-19 |