← Product Code [JNO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO) · K811805

# TRYPIN (125I) RIA KIT (K811805)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · JNO · Aug 31, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K811805

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [JNO](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO.md)
- **Decision Date:** Aug 31, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1725
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K811805](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JNO/K811805)

**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