FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FreeStyle InsuLinx Blood Glucose Monotioring System
K Number: K152328
·
Decision Sep 17, 2015
Classifications
1
FEI Numbers
67
Registration Numbers
68
Same Product Code
72
Applicant Total
1
Review Days
30
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Basic Information
- Device Name
- FreeStyle InsuLinx Blood Glucose Monotioring System
- K Number
- K152328
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abott Laboratories
- Date Received
- August 18, 2015
- Decision Date
- September 17, 2015
- Product Code
- LFR
- 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 |
|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | FDA class 2 | Clinical Chemistry |
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