The following data is part of a premarket notification filed by Icn Immunobiologicals with the FDA for Immu-mark(tm) Chlamydia Igg/iga Kit.
| Device ID | K882674 |
| 510k Number | K882674 |
| Device Name: | IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT |
| Classification | Antisera, Immunoperoxidase, Chlamydia Spp. |
| Applicant | ICN IMMUNOBIOLOGICALS P.O. BOX 1200 Lisle, IL 60532 |
| Contact | L. G Sudbury |
| Correspondent | L. G Sudbury ICN IMMUNOBIOLOGICALS P.O. BOX 1200 Lisle, IL 60532 |
| Product Code | LKH |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-28 |
| Decision Date | 1989-08-15 |