DFC

Lipoprotein, Low-Density, Antigen, Antiserum, Control

Product code
DFC
Device name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Device class
Class 2
21 CFR
21 CFR 866.5600
Medical specialty
Immunology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
43 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-06-16.

NumberDecision dateApplicantDevice nameSummary
K2530692026-06-16Diazyme Laboratories, Inc.Lipoprotein (a) Molarity AssayPDF
K2412202025-01-24Roche Diagnostics OperationsTina-quant Lipoprotein(a) Gen.2 MolarityPDF

2 summaries are archived here for direct download.

Official FDA classification page: DFC
Classification and pathway per current FDA publications. Data from openFDA (CC0).