The following data is part of a premarket notification filed by Ibl Gmbh with the FDA for Luminescent Immunoassay Kit For The Detection Of Progesterone In Saliva.
| Device ID | K040923 |
| 510k Number | K040923 |
| Device Name: | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA |
| Classification | Radioimmunoassay, Progesterone |
| 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 | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-08 |
| Decision Date | 2004-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049325003613 | K040923 | 000 |
| 04049325003606 | K040923 | 000 |
| 04049325003538 | K040923 | 000 |
| 04049325003521 | K040923 | 000 |
| 00404847441581 | K040923 | 000 |
| 00404847441574 | K040923 | 000 |