The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids-isys Ostase Bap.
| Device ID | K200475 |
| 510k Number | K200475 |
| Device Name: | IDS-iSYS Ostase BAP |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| 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 | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-26 |
| Decision Date | 2020-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060169695801 | K200475 | 000 |