The following data is part of a premarket notification filed by Apple Diagnostic Products with the FDA for Applelisa Chlamydia Trachomatis Anti.
| Device ID | K843120 |
| 510k Number | K843120 |
| Device Name: | APPLELISA CHLAMYDIA TRACHOMATIS ANTI |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | APPLE DIAGNOSTIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-08 |
| Decision Date | 1984-09-12 |