FDA product code · Hematology

Red-Cell Count By Photometry

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

LKZClass II21 CFR 864.7100510(k) required2 decisions since 19830 recalls

2 FDA decisions since 1983. 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 LKZ 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 · LKZ

FDA has decided no LKZ device since 2007.

Median 510(k) review, days · LKZ

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

Recalls per year · LKZ

No recall names LKZ since 2007.

Adverse event reports per year · LKZ

No MAUDE report names LKZ since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in LKZ? 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

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Other codes under 21 CFR 864.7100.

JBE Cell Enzymes (Erythrocytic And Leukocytic)

Red-Cell Count By Photometry

What has FDA decided in LKZ lately?

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