The following data is part of a premarket notification filed by Savyon Diagnostics, Ltd. with the FDA for Serolisa Chlamydia Igg Test Kit.
| Device ID | K915281 |
| 510k Number | K915281 |
| Device Name: | SEROLISA CHLAMYDIA IGG TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | SAVYON DIAGNOSTICS, LTD. P.O.BOX 900 Sheva, Israel, IL 84106 |
| Contact | Yakir |
| Correspondent | Yakir SAVYON DIAGNOSTICS, LTD. P.O.BOX 900 Sheva, Israel, IL 84106 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-25 |
| Decision Date | 1992-03-23 |