510(k) Report

FDA product code · Pathology

Immunohistochemistry Assay, Antibody, Met

SERClass III21 CFR 864.1860PMA required1 decision since 20250 recalls

1 FDA decision since 2025. No recall names this code.

The MET antibody is a qualitative immunohistochemical antibody intended to identify MET protein expression in human clinical tissue specimens. The MET antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.

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, pathology panel

Twenty years of SER 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 · SER

3in 2025

2025: 32026 (partial year): 1
2007high 3 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SER

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

Recalls per year · SER

No recall names SER since 2007.

Adverse event reports per year · SER

No MAUDE report names SER 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
20253—00
20261—0—
FIG. 1 — SER by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

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Related product codes

Other codes under 21 CFR 864.1860.