← Product Code [KHP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP) · K936066

# STAT PROFILE PLUS 9 ANALYZER (K936066)

_Nova Biomedical Corp. · KHP · Mar 9, 1995 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K936066

## Device Facts

- **Applicant:** Nova Biomedical Corp.
- **Product Code:** [KHP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP.md)
- **Decision Date:** Mar 9, 1995
- **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).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K936066](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHP/K936066)

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