510(k) Report

FDA product code · Immunology

Iga, Ferritin, Antigen, Antiserum, Control

CZMClass II21 CFR 866.5510510(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 CZM 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 · CZM

FDA has decided no CZM device since 2007.

Median 510(k) review, days · CZM

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

Recalls per year · CZM

No recall names CZM since 2007.

Adverse event reports per year · CZM

No MAUDE report names CZM 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 — CZM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CZM? 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 CZM lately?

  • K870930Tina-Quant (R) (a) C3Boehringer Mannheim Corp. · 1987

The one CZM decision →

Related product codes

Other codes under 21 CFR 866.5510.

DGP Ige, Fitc, Antigen, Antiserum, ControlPCO Immunoglobulin G Lambda Heavy And Light Chain…CZN Iga, Fitc, Antigen, Antiserum, ControlCFQ Radioimmunoassay, Immunoglobulins (G, A, M)DEW Igg, Antigen, Antiserum, ControlPDE Immunoglobulin M Kappa Heavy And Light Chain…DAH Gamma Globulin, Antigen, Antiserum, ControlPDF Immunoglobulin M Lambda Heavy And Light Chain…DFO Igg, Rhodamine, Antigen, Antiserum, ControlMLH Strip, Hama Igg, Elisa, In Vitro Test SystemCZK Iga, Rhodamine, Antigen, Antiserum, ControlDAA Igg, Peroxidase, Antigen, Antiserum, Control