510(k) Report

FDA product code · Microbiology

Antisera, Fluorescent, All Types, Escherichia Coli

GMYClass I21 CFR 866.3255510(k) exempt2 decisions since 19770 recalls

FDA lists GMY as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1977. 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, microbiology panel

Twenty years of GMY 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 · GMY

FDA has decided no GMY device since 2007.

Median 510(k) review, days · GMY

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

Recalls per year · GMY

No recall names GMY since 2007.

Adverse event reports per year · GMY

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

Planning a device in GMY? 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 GMY lately?

  • K770833Fluoretec-MPfizer, Inc. · 1977
  • K770801Microbio. Prod. Fluorescent AntibodyPfizer Pharmaceuticals · 1977

All 2 GMY decisions →

Related product codes

Other codes under 21 CFR 866.3255.

GNA Antisera, All Types, Escherichia ColiGMZ Antigens, All Types, Escherichia Coli