The following data is part of a premarket notification filed by Chronimed, Inc. with the FDA for Quicktek Blood Glucose System, Quicktek Blood Glucose Meter, Quicktek Blood Glucose Strips, Quicktek Control Solution.
| Device ID | K010039 |
| 510k Number | K010039 |
| Device Name: | QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | CHRONIMED, INC. 6214 BURY DR. Eden Prairie, MN 55346 |
| Contact | Bruce A Macfarlane |
| Correspondent | Bruce A Macfarlane CHRONIMED, INC. 6214 BURY DR. Eden Prairie, MN 55346 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-05 |
| Decision Date | 2001-08-10 |