← Product Code [DOP](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DOP) · K770994

# FURNACE AUTOSAMPLER, MODEL 155 (K770994)

_Instrumentation Laboratory CO · DOP · Aug 22, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DOP/K770994

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [DOP](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DOP.md)
- **Decision Date:** Aug 22, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2860
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DOP/K770994](https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DOP/K770994)

**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