FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON Ferritin
K Number: K193650
·
Decision Sep 14, 2021
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
71
Review Days
624
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Basic Information
- Device Name
- LIAISON Ferritin
- K Number
- K193650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaSorin, Inc.
- Date Received
- December 30, 2019
- Decision Date
- September 14, 2021
- Product Code
- DBF
- 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 |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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|---|---|---|---|
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| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | Feb 18, 2021 | Substantially Equivalent |
| K210272 | LIAISON Anti-HAV | Feb 9, 2021 | Substantially Equivalent |
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