QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION— 510(k) K010039
Substantially EquivalentChronimed, Inc.
FDA 510(k) clearance K010039 for QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION, Substantially Equivalent on 2001-08-10. Applicant: Chronimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Chronimed, Inc.
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code NBW
view all- K260738 — Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System
- K261293 — EASYMAX Voice Blood Glucose Monitoring System
- K260687 — VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more
- K260689 — CVS Advanced PLUS Blood Glucose Monitoring System
- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
More clearances from Chronimed, Inc.
view allAdverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.