← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DHB — System, Test, Radioallergosorbent (Rast) Immunological

DEVICE CLASS
Class II
REGULATION
21 CFR 866.5750
MEDICAL SPECIALTY
Immunology
REVIEW PANEL
IM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K260280Hycor Biomedical · 510k2026-06-18
K260059Hycor Biomedical · 510k2026-05-15
K252775Hycor Biomedical · 510k2026-01-16
K252493Hycor Biomedical · 510k2025-12-23
K242531Hycor Biomedical · 510k2025-04-23

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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