The following data is part of a premarket notification filed by Fairleigh Dickinson Laboratories, Inc. with the FDA for Fdl Elisa For Chlamydia.
| Device ID | K883266 |
| 510k Number | K883266 |
| Device Name: | FDL ELISA FOR CHLAMYDIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | FAIRLEIGH DICKINSON LABORATORIES, INC. 1249 AMBLER AVE. Abilene, TX 79601 |
| Contact | Terry L Foster |
| Correspondent | Terry L Foster 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 | 1988-08-03 |
| Decision Date | 1988-10-25 |