510(k) Report

FDA product code · Immunology

Complement C1s, Antigen, Antiserum, Control

CZYClass II21 CFR 866.5240510(k) required1 decision since 19870 recalls

1 FDA decision since 1987. 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, immunology panel

Twenty years of CZY 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.

FDA decisions per year · CZY

FDA has decided no CZY device since 2007.

Median 510(k) review, days · CZY

Too few CZY 510(k)s in any year since 2007 to give a median.

Recalls per year · CZY

No recall names CZY since 2007.

Adverse event reports per year · CZY

No MAUDE report names CZY since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — CZY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CZY? 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

What has FDA decided in CZY lately?

  • K874379Cic-Raji Cell Replacement Enzyme ImmunoassayCytotech, Inc. · 1987

The one CZY decision →

Related product codes

Other codes under 21 CFR 866.5240.

CZW Complement C3, Antigen, Antiserum, ControlDAE Complement C9, Antigen, Antiserum, ControlDAG Complement C8, Antigen, Antiserum, ControlDBI Complement C4, Antigen, Antiserum, ControlDAI Complement C1r, Antigen, Antiserum, ControlDAY Complement C5, Antigen, Antiserum, ControlKTM C3-Indirect Immunofluorescent Solid PhaseDAK Complement C1q, Antigen, Antiserum, Control