ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
FDA 510(k) K173726 · Phadia AB
510(k) numberK173726
Submission
- Device name
- ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
- Applicant
- Phadia AB
Uppsala, SE - Received
- December 5, 2017
- Decision date
- April 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DHB – System, Test, Radioallergosorbent (Rast) Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5750
- Specialty
- Immunology
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| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture…DHB · Traditional | Hycor Biomedical | 01/16/2026SE |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent…DHB · Traditional | Hycor Biomedical | 12/23/2025SE |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum…DHB · Traditional | Hycor Biomedical | 04/23/2025SE |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…DHB · Traditional | Phadia AB | 08/03/2022SE |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaDHB · Traditional | Hycor Biomedical | 02/18/2022SE |
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Questions and answers
When was ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut cleared by the FDA?
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut (K173726) received a 510(k) decision of Substantially Equivalent on April 16, 2018, 132 days after the submission was received.
What is the product code of K173726?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.