← Product Code [JFJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ) · K861269

# RAICHEM AMYLASE REAGENT (K861269)

_Reagents Applications, Inc. · JFJ · May 29, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K861269

## Device Facts

- **Applicant:** Reagents Applications, Inc.
- **Product Code:** [JFJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ.md)
- **Decision Date:** May 29, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1070
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K861269](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K861269)

**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