IDTClass I

Apparatus, Melting Point, Paraffin

21 CFR 864.3010 / Pathology

IDT is the FDA product code for Apparatus, Melting Point, Paraffin, a class I device type, regulated under 21 CFR 864.3010. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: IDT
Device name: Apparatus, Melting Point, Paraffin
Regulation: 21 CFR 864.3010
Device class: Class I
Review panel: Pathology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code IDT

FDA records hold no clearances under product code IDT.

Recent recalls

Product code IDT

Z-1319-2016Class IIIMultiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened...Richard-Allan Scientific Company / initiated 2016-02-16 / 29 cases (10 bags per case)

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)