Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria— 510(k) K220162

Name: FDA 510(k) clearance K220162
Creator: U.S. Food and Drug Administration
Published: 2022-02-18

Substantially Equivalent

Hycor Biomedical

FDA 510(k) clearance K220162 for Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria, Substantially Equivalent on 2022-02-18. Applicant: Hycor Biomedical. Device class: 2.

Clearance details

Applicant: Hycor Biomedical
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 2022-01-20
Decision date: 2022-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DHB

view all

K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)2026-09-04
K261027 — NOVEOS Specific IgE (sIgE) +5 more2026-07-24
K260591 — NOVEOS Specific IgE (sIgE) +5 more2026-07-21
K260280 — NOVEOS Specific IgE (sIgE) +5 more2026-06-18
K260059 — NOVEOS Specific IgE (sIgE) +8 more2026-05-15

More clearances from Hycor Biomedical

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.