Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1450](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1450) → NGD — Test, Lactic Acid, Over The Counter

# NGD · Test, Lactic Acid, Over The Counter

_Clinical Chemistry · 21 CFR 862.1450 · Class 1_

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

## Overview

- **Product Code:** NGD
- **Device Name:** Test, Lactic Acid, Over The Counter
- **Regulation:** [21 CFR 862.1450](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1450)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## 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).

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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