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 862.1120](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1120) → SFO — Electrode Measurement, Drain Effluent Ph

# SFO · Electrode Measurement, Drain Effluent Ph

_Clinical Chemistry · 21 CFR 862.1120 · Class 2_

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

## Overview

- **Product Code:** SFO
- **Device Name:** Electrode Measurement, Drain Effluent Ph
- **Regulation:** [21 CFR 862.1120](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1120)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243965](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/SFO/K243965.md) | Origin™ | Nerv Technology Inc. (D.B.A.) Fluidai Medical | Aug 21, 2025 | SESE |

## Top Applicants

- Nerv Technology Inc. (D.B.A.) Fluidai Medical — 1 clearance

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

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