FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO AVIE A1C TEST SYSTEM
K Number: K091400
·
Decision Jun 11, 2009
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
4
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODIFICATION TO AVIE A1C TEST SYSTEM
- K Number
- K091400
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mec Dynamics Corp
- Date Received
- May 12, 2009
- Decision Date
- June 11, 2009
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCP), ordered by most recent decision date.
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Q-Pad Test System
FDA 510(k)
FDA Class 2
·Hematology
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Aina HbA1c Monitoring System 2
FDA 510(k)
FDA Class 2
·Hematology
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
FDA 510(k)
FDA Class 2
·Hematology
OneDraw A1C Test System
FDA 510(k)
FDA Class 2
·Hematology