FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION
K Number: K010039
·
Decision Aug 10, 2001
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
5
Review Days
217
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Basic Information
- Device Name
- QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION
- K Number
- K010039
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chronimed, Inc.
- Date Received
- January 5, 2001
- Decision Date
- August 10, 2001
- Product Code
- NBW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | FDA class 2 | Clinical Chemistry |
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Other Clearances by Chronimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983432 | SUPREME II CONTROL SOLUTIONS | Dec 17, 1998 | Substantially Equivalent |
| K980573 | SENSOREX BLOOD GLUCOSE MONITORING SYSTEM | Jul 30, 1998 | Substantially Equivalent |
| K981555 | DIASCREEN REAGENT STRIPS | Jun 1, 1998 | Substantially Equivalent |
| K963544 | SUPREME II METER | Feb 20, 1997 | Substantially Equivalent |