FDA product code · Pathology

Quality Control For Molecular Immunohematology Tests

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

PFKClass II21 CFR 864.9650510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.

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, pathology panel

Twenty years of PFK 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 — PFK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PFK? 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 864.9650.

KSF Kit, Quality Control For Blood Banking Reagents