FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON Anti-HAV; LIAISON XS
K Number: K223403
·
Decision Dec 9, 2022
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
22
Applicant Total
22
Review Days
30
Basic Information
- Device Name
- LIAISON Anti-HAV; LIAISON XS
- K Number
- K223403
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3310
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaSorin Inc.
- Date Received
- November 9, 2022
- Decision Date
- December 9, 2022
- Product Code
- LOL
- 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 |
|---|---|---|---|
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | FDA class 2 | Microbiology |
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Other Clearances by DiaSorin Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | Oct 28, 2019 | Substantially Equivalent |