510(k) K010039
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION by
Chronimed, Inc.
— Product Code NBW
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2001
- Date Received
- January 5, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Blood Glucose, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type