PFKClass II

Quality Control For Molecular Immunohematology Tests

21 CFR 864.9650 / Hematology

PFK is the FDA product code for Quality Control For Molecular Immunohematology Tests, a class II device type, regulated under 21 CFR 864.9650. FDA's definition for this code reads: "The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PFK
Device name: Quality Control For Molecular Immunohematology Tests
FDA definition: The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.
Regulation: 21 CFR 864.9650
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PFK

FDA records hold no clearances under product code PFK.

Recent recalls

Product code PFK

FDA records show no recalls under product code PFK.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)