The following data is part of a premarket notification filed by Savyon Diagnostics, Ltd. with the FDA for Ipazyme (tm) Chlamydia Igg-iga.
| Device ID | K910644 |
| 510k Number | K910644 |
| Device Name: | IPAZYME (TM) CHLAMYDIA IGG-IGA |
| Classification | Antisera, Immunoperoxidase, Chlamydia Spp. |
| Applicant | SAVYON DIAGNOSTICS, LTD. KIRYAT MINRAV HABOSEM 3, Ashdod, IL 77101 |
| Contact | Emmanuel A Rosen |
| Correspondent | Emmanuel A Rosen SAVYON DIAGNOSTICS, LTD. KIRYAT MINRAV HABOSEM 3, Ashdod, IL 77101 |
| Product Code | LKH |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-14 |
| Decision Date | 1991-03-19 |