FDA product code · Microbiology

Kit, Direct Antigen, Negative Control

Name: FDA decisions, review times, recalls and adverse event reports for product code MKA
Creator: 510(k) Report

MKAClass I21 CFR 862.1660510(k) exempt0 decisions0 recalls

FDA lists MKA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 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, microbiology panel

Twenty years of MKA 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.

FIG. 1 — MKA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MKA? 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

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