The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Chlamydia Direct Detection (fa) Test.
| Device ID | K853738 |
| 510k Number | K853738 |
| Device Name: | ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| 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 | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-06 |
| Decision Date | 1985-12-06 |