FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
K Number: K161899
·
Decision Jul 28, 2016
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
32
Review Days
17
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Basic Information
- Device Name
- ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
- K Number
- K161899
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phadia AB
- Date Received
- July 11, 2016
- Decision Date
- July 28, 2016
- Product Code
- DGC
- 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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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| K210902 | EliA Ro52, EliA Ro60 | Jul 27, 2022 | Substantially Equivalent |
| K202540 | EliA Rib-P | Sep 13, 2021 | Substantially Equivalent |
| K202541 | EliA RNA Pol III | Sep 13, 2021 | Substantially Equivalent |
| K202067 | EliA SmDP-S | Jul 14, 2021 | Substantially Equivalent |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | May 1, 2020 | Substantially Equivalent |
| K190710 | EliA SymphonyS Immunoassay | Nov 29, 2019 | Substantially Equivalent |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat | May 14, 2019 | Substantially Equivalent |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | Mar 1, 2019 | Substantially Equivalent |
| K183007 | EliA SmDP Immunoassay | Dec 24, 2018 | Substantially Equivalent |