The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids Shbg.
| Device ID | K190121 |
| 510k Number | K190121 |
| Device Name: | IDS SHBG |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | Immunodiagnostic Systems Ltd. 10 Didcot Way Boldon Business Park Boldon, GB Ne35 9pd |
| Contact | Mick Henderson |
| Correspondent | Mick Henderson Immunodiagnostic Systems Ltd. 10 Didcot Way Boldon Business Park Boldon, GB Ne35 9pd |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-25 |
| Decision Date | 2019-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060169691322 | K190121 | 000 |