← Product Code [JRA](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRA) · K963268

# GENESIS RMP (K963268)

_Tecan U.S., Inc. · JRA · Mar 18, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRA/K963268

## Device Facts

- **Applicant:** Tecan U.S., Inc.
- **Product Code:** [JRA](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRA.md)
- **Decision Date:** Mar 18, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2680
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure “micro” volume of a known standardized solution.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRA/K963268](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRA/K963268)

**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