← Product Code [CIB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB) · K940004

# AI-PHOTODIAGNOSTIC (K940004)

_Pharmarceutical Discovery Corp. · CIB · Aug 4, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K940004

## Device Facts

- **Applicant:** Pharmarceutical Discovery Corp.
- **Product Code:** [CIB](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB.md)
- **Decision Date:** Aug 4, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1085
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K940004](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K940004)

**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