New Allerg. Coated Microfilter Well Stri
FDA 510(k) K843302 · Diagnostic Reagent Tech.
510(k) numberK843302
Submission
- Device name
- New Allerg. Coated Microfilter Well Stri
- Applicant
- Diagnostic Reagent Tech.
Mchenry, IL, US - Received
- August 23, 1984
- Decision date
- October 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…DHB · Traditional | Phadia AB | 08/03/2022SE |
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More from Hycor Biomedical
| 510(k) | Device | Decision |
|---|---|---|
| K832345 | Polystyrene Microtiter Well ImmunosorDGC · Traditional | 11/25/1983SE |
| K832344 | Polystyrene Microtiter Plate Immuno-DHB · Traditional | 11/21/1983SE |
| K831984 | Polystyrene Micro-Liter Plate-BirchtreeDGO · Traditional | 11/21/1983SE |
| K831496 | Allergen Immunosorbents Ip Specific E · Traditional | 08/08/1983SE |
| K831774 | Logipe a Data Reducsystem Ip Specific-DGO · Traditional | 07/18/1983SE |
| K830005 | Ip Specific GDAA · Traditional | 06/02/1983SE |
| K830653 | Polystyrene Microtiter Plate ImmunosorbDGO · Traditional | 04/08/1983SE |
| K830495 | Polystyrene Microtiter Plate ImmunosorDGO · Traditional | 04/05/1983SE |
| K821094 | Ip Specific EDGO · Traditional | 05/07/1982SE |
Questions and answers
When was New Allerg. Coated Microfilter Well Stri cleared by the FDA?
New Allerg. Coated Microfilter Well Stri (K843302) received a 510(k) decision of Substantially Equivalent on October 4, 1984, 42 days after the submission was received.
What is the product code of K843302?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.