The following data is part of a premarket notification filed by International Technidyne Corporation with the FDA for Irma Trupoint Creatinine Control Kit.
| Device ID | K050983 |
| 510k Number | K050983 |
| Device Name: | IRMA TRUPOINT CREATININE CONTROL KIT |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | INTERNATIONAL TECHNIDYNE CORPORATION 2656 PATTON RD. Roseville, MN 55113 |
| Contact | Nancy Ring |
| Correspondent | Nancy Ring INTERNATIONAL TECHNIDYNE CORPORATION 2656 PATTON RD. Roseville, MN 55113 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-19 |
| Decision Date | 2005-05-16 |
| Summary: | summary |