The following data is part of a premarket notification filed by Savyon Diagnostics, Ltd. with the FDA for Seroelisa(tm) Chlamydia Iga Test Kit.
| Device ID | K914327 |
| 510k Number | K914327 |
| Device Name: | SEROELISA(TM) CHLAMYDIA IGA TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | SAVYON DIAGNOSTICS, LTD. KIRYAT MINRAV HABOSEM 3, Ashdod, IL 77101 |
| Contact | Yakir |
| Correspondent | Yakir SAVYON DIAGNOSTICS, LTD. KIRYAT MINRAV HABOSEM 3, Ashdod, IL 77101 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-27 |
| Decision Date | 1992-06-09 |