FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K Number: K052838
·
Decision Nov 9, 2005
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
14
Applicant Total
319
Review Days
33
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Basic Information
- Device Name
- LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
- K Number
- K052838
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad
- Date Received
- October 7, 2005
- Decision Date
- November 9, 2005
- Product Code
- GGM
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| GGM | Control, Hemoglobin | FDA class 2 | Hematology |
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