← Product Code [JJE](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE) · K930489

# AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS (K930489)

_E.I. Dupont DE Nemours & Co., Inc. · JJE · May 12, 1993 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE/K930489

## Device Facts

- **Applicant:** E.I. Dupont DE Nemours & Co., Inc.
- **Product Code:** [JJE](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE.md)
- **Decision Date:** May 12, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2160
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE/K930489](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE/K930489)

**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