K252493

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)

510(k) number: K252493
Device name: 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 CA · US
Product code: DHB — System, Test, Radioallergosorbent (Rast) Immunologic
Decision date: 2025-12-23
Date received: 2025-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Immunology

PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K252493.pdf

Official FDA record: K252493

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.