FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
K Number: K120759
·
Decision Jun 5, 2012
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
27
Review Days
84
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Basic Information
- Device Name
- CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
- K Number
- K120759
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- I-Sens, Inc.
- Date Received
- March 13, 2012
- Decision Date
- June 5, 2012
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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