← Product Code [KHP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP) · K852261

# YSI MODEL 2372 TOTAL BLOOD LACTATE KIT (K852261)

_Yellow Springs Instrument Co., Inc. · KHP · Aug 15, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K852261

## Device Facts

- **Applicant:** Yellow Springs Instrument Co., Inc.
- **Product Code:** [KHP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP.md)
- **Decision Date:** Aug 15, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1450
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K852261](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K852261)

**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
