← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DFC — Lipoprotein, Low-Density, Antigen, Antiserum, Control

DEVICE CLASS
Class II
REGULATION
21 CFR 866.5600
MEDICAL SPECIALTY
Immunology
REVIEW PANEL
IM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K253069Diazyme Laboratories, Inc. · 510k2026-06-16
K241220Roche Diagnostics Operations · 510k2025-01-24

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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