510(k) Report

FDA product code · Microbiology

Antisera, Cf, Coxsackievirus A 1-24, B 1-6

GNOClass I21 CFR 866.3145510(k) exempt1 decision since 19850 recalls

FDA lists GNO 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. 1 FDA decision since 1985. 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 GNO 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 · GNO

FDA has decided no GNO device since 2007.

Median 510(k) review, days · GNO

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

Recalls per year · GNO

No recall names GNO since 2007.

Adverse event reports per year · GNO

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

Planning a device in GNO? 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 GNO lately?

  • K853279Coxsackie A2 CF Antigen, A4, A10 & A16Hillcrest Biologicals · 1985

The one GNO decision →

Related product codes

Other codes under 21 CFR 866.3145.

GNN Antisera, Neutralization, Coxsackievirus A…GNG Antigens, Cf (Including Cf Control)…GNM Antisera, Fluorescent, Coxsackievirus A 1-24…