FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
K Number: K122397
·
Decision Sep 6, 2012
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
71
Review Days
30
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Basic Information
- Device Name
- LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
- K Number
- K122397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaSorin, Inc.
- Date Received
- August 7, 2012
- Decision Date
- September 6, 2012
- Product Code
- LFX
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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