FDA product code · Hematology

Fibrinogen And Split Products, Antigen, Antiserum, Control

Name: FDA decisions, review times, recalls and adverse event reports for product code DAZ
Creator: 510(k) Report

DAZClass II21 CFR 864.7340510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, hematology panel

Twenty years of DAZ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — DAZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DAZ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 864.7340.

GIL Plasma, Fibrinogen Control GFK Fibrinogen Determination Standards And Controls GFX Fibrinogen Standard DAT Fibrinogen And Split Products, Peroxidase…DAR Fibrinogen And Split Products, Rhodamine…DAX Fibrinogen And Split Products, Fitc, Antigen…GIS Test, Fibrinogen KQJ System, Fibrinogen Determination