866.5750 Radioallergosorbent Immunlogical Test Sys
FDA 510(k) K914685 · In Vitro Technologies, Inc.
510(k) numberK914685
Submission
- Device name
- 866.5750 Radioallergosorbent Immunlogical Test Sys
- Applicant
- In Vitro Technologies, Inc.
Arlington, TX, US - Received
- October 18, 1991
- Decision date
- September 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture…DHB · Traditional | Hycor Biomedical | 07/21/2026SE |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture…DHB · Traditional | Hycor Biomedical | 06/18/2026SE |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa)…DHB · Traditional | Hycor Biomedical | 05/15/2026SE |
| 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 |
More from Hycor Biomedical
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|---|---|---|
| K904661 | Ivt Rast TracerDHB · Traditional | 11/29/1990SE |
| K875329 | Ivt Central Allergy ScreenDHB · Traditional | 04/07/1988SE |
| K875328 | Ivt Western Allergy ScreenDHB · Traditional | 03/23/1988SE |
| K874169 | Ivt Northeast Allergy ScreenDHB · Traditional | 01/11/1988SE |
| K874168 | Ivt Southeast Allergy ScreenDHB · Traditional | 01/11/1988SE |
| K870625 | Ivt Southwest Allergy ScreenDHB · Traditional | 05/01/1987SE |
Questions and answers
When was 866.5750 Radioallergosorbent Immunlogical Test Sys cleared by the FDA?
866.5750 Radioallergosorbent Immunlogical Test Sys (K914685) received a 510(k) decision of Substantially Equivalent on September 14, 1992, 332 days after the submission was received.
What is the product code of K914685?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.