The following data is part of a premarket notification filed by Swedish Trade Council Usa with the FDA for Renalyzer Prx 90.
| Device ID | K903034 |
| 510k Number | K903034 |
| Device Name: | RENALYZER PRX 90 |
| Classification | Electrode, Ion Based, Enzymatic, Creatinine |
| Applicant | SWEDISH TRADE COUNCIL USA 150 NORTH MICHIGAN AVE. SUITE 1200 Chicago, IL 60601 |
| Contact | Anders Sjoberg |
| Correspondent | Anders Sjoberg SWEDISH TRADE COUNCIL USA 150 NORTH MICHIGAN AVE. SUITE 1200 Chicago, IL 60601 |
| Product Code | CGL |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1991-03-13 |