NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut
Hycor Biomedical · Immunology
Open FDA's page for this record- Third party flag
- N
- City
- Garden Grove
- Advisory committee description
- Immunology
- Address 1
- 7272 Chapman Ave.
- Statement or summary
- Summary
- Product code
- DHB
- Zip code
- 92841
- Applicant
- Hycor Biomedical
- Decision date
- 2026-07-21
- Decision code
- SESE
- Country code
- US
- Advisory committee
- IM
- Contact
- Hiromi Kubota
- K number
- K260591
- State
- CA
- Date received
- 2026-02-23
- Review advisory committee
- IM
- Postal code
- 92841
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut
- Harmonized identifiers (openFDA)
- Device name
- System, Test, Radioallergosorbent (Rast) Immunological
- Medical specialty description
- Immunology
- Regulation number
- 866.5750
- Device class
- 2
- Registration number
- 2029275, 3003477135, 2432235, 2016473, 2022994, 1423662, 1036362, 3002806944, 3039353646, 2517506, 9610566, 3006198300, 3013521527, 2936856, 9610865, 3004973408, 3031570369
- FEI number
- 3003477135, 2432235, 2022994, 1000306431, 3002806944, 1036362, 3039353646, 2517506, 3006198300, 3013521527, 2936856, 3002806350, 3000215273, 3004973408, 1000125787, 3031570369, 3002807876