Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies
FDA 510(k) K122197 · Phadia US, Inc.
510(k) numberK122197
Submission
- Device name
- Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies
- Applicant
- Phadia US, Inc.
Portage, MI, US - Received
- July 24, 2012
- Decision date
- August 28, 2013
- 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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| 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 |
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Questions and answers
When was Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies cleared by the FDA?
Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies (K122197) received a 510(k) decision of Substantially Equivalent on August 28, 2013, 400 days after the submission was received.
What is the product code of K122197?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.