Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6
FDA 510(k) K100910 · Siemens Medical Solutions Diagnostics
510(k) numberK100910
Submission
- Device name
- Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6
- Applicant
- Siemens Medical Solutions Diagnostics
Los Angeles, CA, US - Received
- April 1, 2010
- Decision date
- May 11, 2011
- 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 Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6 cleared by the FDA?
Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6 (K100910) received a 510(k) decision of Substantially Equivalent on May 11, 2011, 405 days after the submission was received.
What is the product code of K100910?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.