PKMNot classified

Chemiluminescent Immunoassay System

Unknown

PKM is the FDA product code for Chemiluminescent Immunoassay System. FDA's definition for this code reads: "For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PKM
Device name: Chemiluminescent Immunoassay System
FDA definition: For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum.
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Siemens Healthcare Diagnostics Inc.

Recent clearances

Product code PKM

FDA records hold no clearances under product code PKM.

Recent recalls

Product code PKM

FDA records show no recalls under product code PKM.

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)