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 |