IDMClass I

Microtome, Ultra

21 CFR 864.3010 / Pathology

IDM is the FDA product code for Microtome, Ultra, a class I device type, regulated under 21 CFR 864.3010. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1981-09-16, and no recalls.

Classification record

Product code: IDM
Device name: Microtome, Ultra
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: 1
Ingested recalls: 0

Clearances, product code IDM

By decision year

1 clearance under product code IDM with a decision year between 1981 and 1981, 1981 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code IDM by decision year
Year	Clearances
1981	1

Applicants with the most clearances

Product code IDM

Applicants holding the most 510(k) clearances under product code IDM
Applicant	Clearances
Lkb Instruments, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Labotek Group Corp

Recent clearances

Product code IDM

K812158Class ILkb-Bromma 2188 Ultrotome NovaLkb Instruments, Inc. / cleared 1981-09-16

Recent recalls

Product code IDM

FDA records show no recalls under product code IDM.

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)