The following data is part of a premarket notification filed by Savyon Diagnostics, Ltd. with the FDA for Ipazyme(tm) Chlamydia True Igm(tm).
| Device ID | K901975 |
| 510k Number | K901975 |
| Device Name: | IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) |
| Classification | Antisera, Immunoperoxidase, Chlamydia Spp. |
| Applicant | SAVYON DIAGNOSTICS, LTD. KIRYAT MINRAV HABOSEM 3, Ashdod, IL 77101 |
| Contact | Dr. Y Yakir |
| Correspondent | Dr. Y Yakir 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 | 1990-05-01 |
| Decision Date | 1991-03-08 |