FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
ARCHITECT IVANCOMYCIN
K Number: K123947
·
Decision Aug 29, 2013
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
30
Applicant Total
23
Review Days
251
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Basic Information
- Device Name
- ARCHITECT IVANCOMYCIN
- K Number
- K123947
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3950
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biokit, S.A.
- Date Received
- December 21, 2012
- Decision Date
- August 29, 2013
- Product Code
- LEH
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LEH | Radioimmunoassay, Vancomycin | FDA class 2 | Clinical Toxicology |
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Other Clearances by Biokit, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Feb 12, 2025 | Substantially Equivalent |
| 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 |
| K110619 | ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS | Nov 23, 2011 | Substantially Equivalent |