The following data is part of a premarket notification filed by Diametrics Medical, Inc. with the FDA for Irma Sl Blood Analysis System Cr Cartridge.
| Device ID | K030035 |
| 510k Number | K030035 |
| Device Name: | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE |
| Classification | Enzymatic Method, Creatinine |
| Applicant | DIAMETRICS MEDICAL, INC. 2658 PATTON RD. Saint Paul, MN 55113 |
| Contact | Nancy Ring |
| Correspondent | Nancy Ring DIAMETRICS MEDICAL, INC. 2658 PATTON RD. Saint Paul, MN 55113 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-03 |
| Decision Date | 2003-06-25 |
| Summary: | summary |