510(k) Report

FDA product code · Microbiology

Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids

NWZClass II21 CFR 866.3045510(k) required1 decision since 20060 recalls

1 FDA decision since 2006. No recall names this code.

Aid in the identification of Bacillus Anthracis

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 NWZ 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 · NWZ

FDA has decided no NWZ device since 2007.

Median 510(k) review, days · NWZ

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

Recalls per year · NWZ

No recall names NWZ since 2007.

Adverse event reports per year · NWZ

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

Planning a device in NWZ? 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 NWZ lately?

  • K052485Sherlock Microbial Identification System for BiodefMidi, Inc. · 2006

The one NWZ decision →

Related product codes

Other codes under 21 CFR 866.3045.

NRL Enzyme Linked Immunoabsorbent Assay, Antibody…NVQ Bacteriophage And Controls, B. Anthracis LysisNHT Assay, Nucleic Acid Amplification, Bacillus…NPO Kit, Immunochromatographic, Bacillus Anthracis…