The following data is part of a premarket notification filed by Fairleigh Dickinson Laboratories, Inc. with the FDA for Modified Elisa For Chlamydia.
| Device ID | K896032 |
| 510k Number | K896032 |
| Device Name: | MODIFIED ELISA FOR CHLAMYDIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | FAIRLEIGH DICKINSON LABORATORIES, INC. 1249 AMBLER AVE. Abilene, TX 79601 |
| Contact | C Mansfield |
| Correspondent | C Mansfield FAIRLEIGH DICKINSON LABORATORIES, INC. 1249 AMBLER AVE. Abilene, TX 79601 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-16 |
| Decision Date | 1990-01-29 |