KTMClass II

C3-Indirect Immunofluorescent Solid Phase

21 CFR 866.5240 / Immunology

KTM is the FDA product code for C3-Indirect Immunofluorescent Solid Phase, a class II device type, regulated under 21 CFR 866.5240. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: KTM
Device name: C3-Indirect Immunofluorescent Solid Phase
Regulation: 21 CFR 866.5240
Device class: Class II
Review panel: Immunology
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

No registered establishment in MDM’s records lists product code KTM.

Recent clearances

Product code KTM

FDA records hold no clearances under product code KTM.

Recent recalls

Product code KTM

FDA records show no recalls under product code KTM.

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)