FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
K Number: K241787
·
Decision Aug 27, 2024
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
7
Review Days
67
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Basic Information
- Device Name
- CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
- K Number
- K241787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ascensia Diabetes Care U.S., Inc.
- Date Received
- June 21, 2024
- Decision Date
- August 27, 2024
- 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 Ascensia Diabetes Care U.S., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250813 | MICROLET®NEXT 2 Lancing Device | May 14, 2025 | Substantially Equivalent |
| K241810 | MICROLET®NEXT Lancet | Aug 15, 2024 | Substantially Equivalent |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Nov 18, 2022 | Substantially Equivalent |
| K220633 | MICROLET NEXT lancing device, MICROLET Lancet | Jun 3, 2022 | Substantially Equivalent |
| K162336 | Contour Next EZ Blood Glucose Monitoring System | Jan 12, 2017 | Substantially Equivalent |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System | Jun 24, 2016 | Substantially Equivalent |