FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON Anti-HAV
K Number: K210272
·
Decision Feb 9, 2021
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
71
Review Days
8
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Basic Information
- Device Name
- LIAISON Anti-HAV
- K Number
- K210272
- 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
- February 1, 2021
- Decision Date
- February 9, 2021
- 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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|---|---|---|---|
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| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | Oct 27, 2023 | Substantially Equivalent |
| K223403 | LIAISON Anti-HAV; LIAISON XS | Dec 9, 2022 | Substantially Equivalent |
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