FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
K Number: K120817
·
Decision Feb 26, 2013
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
93
Applicant Total
126
Review Days
344
Basic Information
- Device Name
- QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
- K Number
- K120817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INOVA DIAGNOSTICS, INC.
- Date Received
- March 19, 2012
- Decision Date
- February 26, 2013
- Product Code
- MID
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | FDA class 2 | Immunology |
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