FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION VISA HBA1C, MODEL K3105A
K Number: K102045
·
Decision Feb 14, 2011
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
3
Review Days
208
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Basic Information
- Device Name
- DIMENSION VISA HBA1C, MODEL K3105A
- K Number
- K102045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Heatlhcare Diagnostics, Inc.
- Date Received
- July 21, 2010
- Decision Date
- February 14, 2011
- Product Code
- LCP
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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