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): 58

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

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

Number	Decision date	Applicant	Device name	Summary
K253985	2026-08-11	Siemens 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).