The following data is part of a premarket notification filed by Chronimed, Inc. with the FDA for Supreme Ii Meter.
| Device ID | K963544 |
| 510k Number | K963544 |
| Device Name: | SUPREME II METER |
| Classification | Glucose Oxidase, Glucose |
| Applicant | CHRONIMED, INC. 6214 BURY DR. Eden Prairie, MN 55346 |
| Contact | Jeffrey P Heaton |
| Correspondent | Jeffrey P Heaton CHRONIMED, INC. 6214 BURY DR. Eden Prairie, MN 55346 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-04 |
| Decision Date | 1997-02-20 |