FDA product code IDM: Microtome, Ultra
IDM is the FDA product code for microtome, ultra. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IDM. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Microtome, Ultra |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IDM clearance
Top IDM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lkb Instruments, Inc. | 1 | 1981-09-16 |
Most recent IDM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812158 | Lkb Instruments, Inc. | LKB-BROMMA 2188 ULTROTOME NOVA | 1981-09-16 | 49 |
Recalls for IDM devices
openFDA lists no recalls for product code IDM.
Frequently asked questions
What is FDA product code IDM?
IDM is the FDA product code for microtome, ultra. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IDM?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IDM?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most IDM clearances?
Lkb Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IDM
- Run a recall and safety report across every IDM manufacturer
- Watch product code IDM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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