FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
K Number: K102751
·
Decision Feb 11, 2013
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
4
Review Days
872
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Basic Information
- Device Name
- LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
- K Number
- K102751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceragem Medisys, Inc.
- Date Received
- September 23, 2010
- Decision Date
- February 11, 2013
- 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 Ceragem Medisys, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141829 | GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM | Sep 24, 2014 | Substantially Equivalent |
| K140141 | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM | Jul 3, 2014 | Substantially Equivalent |
| K131727 | CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM | Feb 28, 2014 | Substantially Equivalent |