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DAP

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Product code
DAP
Device name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device class
Class 2
21 CFR
21 CFR 864.7320
Medical specialty
Hematology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
58 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-08-11.

NumberDecision dateApplicantDevice nameSummary
K2539852026-08-11Siemens Healthcare Diagnostic Products…INNOVANCE® D-Dimer 2.0 (SMN 10873803)PDF

1 summaries are archived here for direct download.

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