NOVEOS Specific IgE (sIgE) Assay +9 more— 510(k) K242531
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K242531 for NOVEOS Specific IgE (sIgE) Assay +9 more, Substantially Equivalent on 2025-04-23. Applicant: Hycor Biomedical. Device class: 2.
Clearance details
- Device name as filed
- NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz
- Applicant
- Hycor Biomedical
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Garden Grove, CA, US
Recent devices under product code DHB
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- K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus +1 more
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