The following data is part of a premarket notification filed by Chronimed, Inc. with the FDA for Supreme Ii Control Solutions.
| Device ID | K983432 |
| 510k Number | K983432 |
| Device Name: | SUPREME II CONTROL SOLUTIONS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CHRONIMED, INC. 10900 RED CIRCLE DR. Minnetonka, MN 55343 |
| Contact | Jeffrey P Heaton |
| Correspondent | Jeffrey P Heaton CHRONIMED, INC. 10900 RED CIRCLE DR. Minnetonka, MN 55343 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-29 |
| Decision Date | 1998-12-17 |