← Product Code [IDM](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IDM) · K812158

# LKB-BROMMA 2188 ULTROTOME NOVA (K812158)

_Lkb Instruments, Inc. · IDM · Sep 16, 1981 · Pathology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IDM/K812158

## Device Facts

- **Applicant:** Lkb Instruments, Inc.
- **Product Code:** [IDM](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IDM.md)
- **Decision Date:** Sep 16, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.3010
- **Device Class:** Class 1
- **Review Panel:** Pathology

## Regulatory Identification

Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IDM/K812158](https://fda.innolitics.com/submissions/HE/subpart-d%E2%80%94pathology-instrumentation-and-accessories/IDM/K812158)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com