NOVEOS Specific IgE (sIgE) +4 more— 510(k) K252493
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K252493 for NOVEOS Specific IgE (sIgE) +4 more, Substantially Equivalent on 2025-12-23. Applicant: Hycor Biomedical. Device class: 2.
Clearance details
- Device name as filed
- NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)
- 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
view allMore clearances from Hycor Biomedical
view all- K252775 — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) +3 more
- K242531 — NOVEOS Specific IgE (sIgE) Assay +9 more
- K220162 — Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
- K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus +1 more
- K191510 — Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
Data sourced from openFDA. This site is unofficial and independent of the FDA.