The following data is part of a premarket notification filed by Ibl Gmbh with the FDA for Ibl C3d-cic Eia Test.
| Device ID | K032796 |
| 510k Number | K032796 |
| Device Name: | IBL C3D-CIC EIA TEST |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | IBL GMBH 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus IBL GMBH 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Product Code | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-08 |
| Decision Date | 2004-01-13 |