The following data is part of a premarket notification filed by Ibl Gmbh with the FDA for Luminescent Immunoassay Kit For The Detection Of Estradiol In Saliva And Serum.
| Device ID | K041349 |
| 510k Number | K041349 |
| Device Name: | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM |
| Classification | Radioimmunoassay, Estradiol |
| 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 | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-09-24 |
| Summary: | summary |