FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TQ HBA1C GEN3
K Number: K102914
·
Decision Jan 20, 2011
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
2
Review Days
111
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Basic Information
- Device Name
- TQ HBA1C GEN3
- K Number
- K102914
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche
- Date Received
- October 1, 2010
- Decision Date
- January 20, 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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| K Number | Device Name | ||
|---|---|---|---|
| K113793 | HOMOCYSTEINE TEST | Jun 5, 2012 | Substantially Equivalent |