FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
K Number: K243575
·
Decision Feb 12, 2025
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
9
Applicant Total
23
Review Days
85
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Basic Information
- Device Name
- ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
- K Number
- K243575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biokit, S.A.
- Date Received
- November 19, 2024
- Decision Date
- February 12, 2025
- Product Code
- MYF
- 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 |
|---|---|---|---|
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MYF), ordered by most recent decision date.
Elecsys HSV-2 IgG (08948887160)
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SeraQuest HSV Type 2 Specific IgG
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ADVIA Centaur Herpes-2 IgG
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SeraQuest HSV Type 2 Specific IgG
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FDA Class 2
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ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
FDA 510(k)
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LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Biokit, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgM | Aug 7, 2024 | Substantially Equivalent |
| K233605 | ADVIA Centaur EBV-EBNA IgG | Aug 7, 2024 | Substantially Equivalent |
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | Sep 20, 2023 | Substantially Equivalent |
| K214068 | Quantia IgE | Feb 21, 2023 | Substantially Equivalent |
| K181334 | ADVIA Centaur Herpes-2 IgG | Aug 23, 2018 | Substantially Equivalent |
| K181333 | ADVIA Centaur Herpes-1 IgG | Aug 23, 2018 | Substantially Equivalent |
| K152185 | ARCHITECT SHBG | Feb 11, 2016 | Substantially Equivalent |
| K132400 | LP(A) CALIBRATORS, AND LP(A) CONTROLS | Dec 19, 2013 | Substantially Equivalent |
| K123947 | ARCHITECT IVANCOMYCIN | Aug 29, 2013 | Substantially Equivalent |
| K110619 | ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS | Nov 23, 2011 | Substantially Equivalent |