The following data is part of a premarket notification filed by Ibl Gmbh with the FDA for Luminescent Immunoassay Kit For The Detection Of Testosterone In Serum And Saliva.
| Device ID | K033786 |
| 510k Number | K033786 |
| Device Name: | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| Subsequent Product Code | CDZ |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-04 |
| Decision Date | 2004-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049325006546 | K033786 | 000 |
| 04049325003545 | K033786 | 000 |