510(k) Report

FDA product code · Immunology

Test, Donor, Syphilis, Antigens, Treponemal

MYRClass II21 CFR 866.3830510(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, immunology panel

Twenty years of MYR 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 · MYR

FDA has decided no MYR device since 2007.

Median 510(k) review, days · MYR

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

Recalls per year · MYR

No recall names MYR since 2007.

Adverse event reports per year · MYR

1in 2022

2016: 22017: 12022: 1
2007high 2 (2016) · low 0 (2007)2025

MAUDE reports naming product code MYR, not matched to any one device; reports are not rates.

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—02
20170—01
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MYR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MYR? 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 866.3830.

LSR Reagent, Borrelia Serological ReagentJWL Antigen, Treponema Pallidum For Fta-Abs TestGMT Antigens, Ha, Treponema PallidumGMS Anti-Human Globulin, Fta-Abs TestLIP Enzyme Linked Immunoabsorption Assay…GMW Test, Sorbent, Fta-AbsGMR Sera, Reactive And Non-Specific Control…GMX Antisera, Fluorescent Antibody For Fta-Abs Test